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| ID | Type | Description | Link |
|---|---|---|---|
| CCR-17-300 | Other Grant/Funding Number | Rising Tide Foundation for Clinical Cancer Research |
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| Name | Class |
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| Rising Tide Foundation | OTHER |
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Purpose: To conduct a randomized controlled pilot study investigating the use of high dose intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium, including health-related quality of life (HRQOL), functional status, and neuropsychiatric outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic hematopoietic stem cell transplant (HSCT).
Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for allogeneic stem cell transplant.
Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will be measured weekly and participants will be assessed for evidence of delirium using validated measures. Validated measures will also be used to assess cognitive function, depression, post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at one, three, and six months after transplant.
Delirium is a common and potentially preventable neuropsychiatric complication in cancer patients receiving hematopoietic stem cell transplantation (HSCT) that has profound consequences. Among cancer patients hospitalized for HSCT, delirium occurs in approximately 40% of patients and increases the risk of mortality. Long-term, delirium in this population results in worse physical health, mental health, and quality of life. Though strategies to prevent delirium have the potential to significantly improve the lives of people living with cancer, research in this area is extremely limited. Thiamine deficiency is also ubiquitous during HSCT and a known contributor to the development of delirium in other patient populations. High dose intravenous (IV) thiamine is an evidence-based and promising treatment for delirium, but no one has studied IV thiamine as a prevention strategy.
This is a randomized double-blind controlled trial in participants undergoing allogeneic HSCT to determine if high dose IV thiamine can prevent delirium and minimize the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and other neuropsychiatric outcomes. The investigators will recruit 60 patients admitted for allogeneic HSCT at UNC, randomize them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluate all participants for delirium and related comorbidities. The investigators will use the Delirium Rating Scale (DRS) to measure the severity and duration of delirium immediately prior to transplant and after HSCT until 30 days post-transplant or discharge. If delirium is identified, the DRS will be administered daily until delirium resolves. The investigators will obtain thiamine levels and other laboratory parameters associated with delirium the day after transplant, and continue to monitor thiamine levels weekly thereafter. The investigators will also monitor HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to transplant and at one, three, and six months after transplant to elucidate the persistent impact of delirium in this population and the potential for thiamine to mitigate these negative outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Thiamine 200 mg IV |
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| Control | Placebo Comparator | Normal saline IV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thiamine | Drug | 200 mg IV three times daily for seven days |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Delirium | Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium incidence will be defined as at least one assessment with DRS > 12. | Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium Severity | Delirium severity will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The score ranges from 0 to 32 with higher scores reflecting more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. The DRS medians and ranges are reported for each group at baseline and in each week of hospitalization for thiamine and placebo groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Rosenstein, MD | University of North Carolina, Chapel Hill | Study Chair |
| Zev Nakamura, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33945982 | Derived | Nakamura ZM, Deal AM, Park EM, Quillen LJ, Chien SA, Stanton KE, McCabe SD, Heiling HM, Wood WA, Shea TC, Rosenstein DL. A randomized double-blind placebo-controlled trial of intravenous thiamine for prevention of delirium following allogeneic hematopoietic stem cell transplantation. J Psychosom Res. 2021 Jul;146:110503. doi: 10.1016/j.jpsychores.2021.110503. Epub 2021 Apr 27. |
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Of the 66 participants who enrolled in the study, 2 withdrew prior to randomization.
Participants were recruited from the UNC Bone Marrow Transplant and Cellular Therapies Unit from October 2017 through February 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Thiamine 200 mg IV Thiamine: 200 mg IV three times daily for seven days |
| FG001 | Control | Normal saline IV Normal saline: Normal saline IV three times daily for seven days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Inpatient Phase |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2020 |
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| Normal saline | Drug | Normal saline IV three times daily for seven days |
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| Assessments will occur in the week prior to transplant (baseline), then at least 3 times post-transplant on a weekly basis until 30 days post-transplant or discharge, whichever comes first, up to week 5 |
| Delirium Duration | Delirium duration will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium duration will be reported as number of consecutive days during which DRS > 12. | Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first. |
| Concentration of Thiamine Status Stratified by Delirium Status | The relationship between thiamine levels at the end of the seven day administration of thiamine and the development of delirium at any point during the thirty days post-transplant or the post-transplant hospitalization, whichever comes first, will be examined. Thiamine levels (nmol/L) are presented in participants who did and did not experience delirium. | From end of 7-day intervention period until the development of delirium at any point during the post-transplant hospitalization up to a maximum of 30 days |
| Change in Health-related Quality of Life Scores (Month 1) | HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time. | From baseline to one month post-transplant |
| Change in Health-related Quality of Life Scores (Month 3) | HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time. | Baseline to three months post-transplant |
| Change in Health-related Quality of Life Scores (Month 6) | HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time. | Baseline to six months post-transplant |
| Change in Depression Scores (Month 1) | Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time. | Baseline to one month post-transplant |
| Change in Depression Scores (Month 3) | Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time. | Baseline to three months post-transplant |
| Change in Depression Scores (Month 6) | Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time. | Baseline to six months post-transplant |
| Change in Post-traumatic Stress Symptom Scores (Month 1) | Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time. | Baseline to one month post-transplant |
| Change in Post-traumatic Stress Symptom Scores (Month 3) | Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time. | Baseline to three months post-transplant |
| Change in Post-traumatic Stress Symptom Scores (Month 6) | Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time. | Baseline to six months post-transplant |
| Change in Cognitive Function Scores (Month 1) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time. | From baseline to one month post-transplant |
| Change in Cognitive Function Scores (Month 3) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time. | Baseline to three months post-transplant |
| Change in Cognitive Function Scores (Month 6) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time. | From baseline to six months post-transplant |
| Change in Functional Status Scores (Month 1) | Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time. | Baseline to one month post-transplant |
| Change in Functional Status Scores (Month 3) | Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time. | From baseline to three months post-transplant |
| Change in Functional Status Scores (Month 6) | Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time. | Baseline to six months post-transplant |
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| NOT COMPLETED |
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| 1-month Follow-Up |
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| 3-month Follow-Up |
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| 6-month Follow-Up |
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Only participants who met the following a priori criteria were counted: 1.) received all seven days of the treatment; 2.) received at least 17/21 (80%) scheduled study drug doses; and 3.) delirium was assessed at least weekly until the participant was found to be delirious, reached 30 days post-transplant, or was discharged.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Thiamine 200 mg IV Thiamine: 200 mg IV three times daily for seven days |
| BG001 | Control | Normal saline IV Normal saline: Normal saline IV three times daily for seven days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Years of education | Mean | Standard Deviation | years |
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| Diagnosis | Count of Participants | Participants |
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| CIBMTR Disease Risk Index | CIBMTR: Center for International Blood and Marrow Transplant Research. Uses disease, stage, and cytogenetics to assigns low, intermediate, high, or very high risk related to overall survival after allogeneic hematopoietic stem cell transplant among patients with hematologic malignancies. | Count of Participants | Participants |
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| Donor Type | Count of Participants | Participants |
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| Conditioning Regimen | Count of Participants | Participants |
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| ECOG Score | A scale by the Eastern Cooperative Oncology Group (ECOG) from 0-5 to describe patient's selfcare ability and activity level. 0, Fully active
| Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Delirium | Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium incidence will be defined as at least one assessment with DRS > 12. | The analysis population was defined a priori as those participants who: 1.) received at least 17 of 21 (80%) scheduled study drug doses; 2.) received at least one dose on each of the study drug administration days; and 3.) had no fewer than one DRS assessment per week until they were found to be delirious, reached 30 days post-transplant, or were discharged. | Posted | Number | percentage of participants | Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first. |
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| Secondary | Delirium Severity | Delirium severity will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The score ranges from 0 to 32 with higher scores reflecting more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. The DRS medians and ranges are reported for each group at baseline and in each week of hospitalization for thiamine and placebo groups. | Attrition over time is due to hospital discharge (primary reason), withdrawal, or death. | Posted | Median | Full Range | score on a scale | Assessments will occur in the week prior to transplant (baseline), then at least 3 times post-transplant on a weekly basis until 30 days post-transplant or discharge, whichever comes first, up to week 5 |
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| Secondary | Delirium Duration | Delirium duration will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium duration will be reported as number of consecutive days during which DRS > 12. | These analyses are exclusive to those participants who experienced delirium. | Posted | Mean | Standard Deviation | days | Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first. |
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| Secondary | Concentration of Thiamine Status Stratified by Delirium Status | The relationship between thiamine levels at the end of the seven day administration of thiamine and the development of delirium at any point during the thirty days post-transplant or the post-transplant hospitalization, whichever comes first, will be examined. Thiamine levels (nmol/L) are presented in participants who did and did not experience delirium. | Only those participants in whom thiamine levels were obtained at the end of the seven day administration were included. | Posted | Mean | Standard Deviation | nmol/L | From end of 7-day intervention period until the development of delirium at any point during the post-transplant hospitalization up to a maximum of 30 days |
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| Secondary | Change in Health-related Quality of Life Scores (Month 1) | HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time. | Participants who completed the 1 month follow-up period. | Posted | Mean | Standard Deviation | score on a scale | From baseline to one month post-transplant |
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| Secondary | Change in Health-related Quality of Life Scores (Month 3) | HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time. | Participants who completed the 3 month follow-up period | Posted | Mean | Standard Deviation | score on a scale | Baseline to three months post-transplant |
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| Secondary | Change in Health-related Quality of Life Scores (Month 6) | HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time. | Participants who completed the 6 month follow-up period | Posted | Mean | Standard Deviation | score on a scale | Baseline to six months post-transplant |
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| Secondary | Change in Depression Scores (Month 1) | Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time. | Participants who completed the 1 month follow-up period. | Posted | Mean | Standard Deviation | T-score | Baseline to one month post-transplant |
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| Secondary | Change in Depression Scores (Month 3) | Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time. | Participants who completed the 3 month follow-up period | Posted | Mean | Standard Deviation | T-score | Baseline to three months post-transplant |
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| Secondary | Change in Depression Scores (Month 6) | Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time. | Participants who completed the 6 month follow-up period | Posted | Mean | Standard Deviation | T-score | Baseline to six months post-transplant |
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| Secondary | Change in Post-traumatic Stress Symptom Scores (Month 1) | Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time. | Participants who completed the 1 month follow-up period. | Posted | Mean | Standard Deviation | score on a scale | Baseline to one month post-transplant |
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| Secondary | Change in Post-traumatic Stress Symptom Scores (Month 3) | Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time. | Participants who completed the 3 month follow-up period | Posted | Mean | Standard Deviation | score on a scale | Baseline to three months post-transplant |
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| Secondary | Change in Post-traumatic Stress Symptom Scores (Month 6) | Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time. | Participants who completed the 6 month follow-up period. | Posted | Mean | Standard Deviation | score on a scale | Baseline to six months post-transplant |
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| Secondary | Change in Cognitive Function Scores (Month 1) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time. | One participant in the control arm was unable to complete the MoCA due to restrictions on in-person human subjects research during the COVID-19 pandemic. Otherwise, all participants available at the 1-month follow-up time point were included. | Posted | Mean | Standard Deviation | score on a scale | From baseline to one month post-transplant |
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| Secondary | Change in Cognitive Function Scores (Month 3) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time. | Participants who completed the 3 month follow-up period and we able to participate in the cognitive assessment. Of the 26 participants active in the thiamine arm at the 3 month follow-up, 1 did not complete this measure due to barriers related to the COVID-19 pandemic. | Posted | Mean | Standard Deviation | score on a scale | Baseline to three months post-transplant |
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| Secondary | Change in Cognitive Function Scores (Month 6) | Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time. | Participants who completed the 6 month follow-up period. | Posted | Mean | Standard Deviation | score on a scale | From baseline to six months post-transplant |
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| Secondary | Change in Functional Status Scores (Month 1) | Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time. | Participants who completed the 1 month follow-up period | Posted | Mean | Standard Deviation | score on a scale | Baseline to one month post-transplant |
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| Secondary | Change in Functional Status Scores (Month 3) | Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time. | Participants who completed the 3 month follow-up. | Posted | Mean | Standard Deviation | score on a scale | From baseline to three months post-transplant |
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| Secondary | Change in Functional Status Scores (Month 6) | Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time. | Participants who completed the 6 month follow-up period. | Posted | Mean | Standard Deviation | score on a scale | Baseline to six months post-transplant |
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Adverse event (AE) data were only collected from October 2017 through February 2020, during the intervention phase of the study and coinciding with participants' hospitalization for hematopoietic stem cell transplantation. This phase lasted up to 30 days for each participant. The study was completed on August 10, 2020, as secondary outcomes were collected for an additional 5 months after completion of AE data collection.
Adverse events were were graded per NCI CTCAE v. 4 criteria.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Thiamine 200 mg IV Thiamine: 200 mg IV three times daily for seven days | 1 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Control | Normal saline IV Normal saline: Normal saline IV three times daily for seven days | 0 | 34 | 0 | 34 | 0 | 34 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zev Nakamura | University of North Carolina - Chapel Hill | 984-974-3829 | zev_nakamura@med.unc.edu |
| Dec 30, 2020 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| D013832 | Thiamine Deficiency |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013831 | Thiamine |
| C000712172 | thiamine hydrochloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Chronic leukemia |
|
| Lymphoma |
|
| Myelodysplastic Syndrome |
|
| Myeloproliferative Disorder |
|
| Other |
|
| low |
|
| intermediate |
|
| high |
|
| Matched Unrelated Donor |
|
| Haploidentical |
|
| Reduced Intensity or Non-Myeloablative |
|
| 1 |
|
| 2 |
|
| Units | Counts |
|---|
| Participants |
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| Participants |
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