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| ID | Type | Description | Link |
|---|---|---|---|
| 00049444 | Other Identifier | Advarra IRB | |
| LCI-SUPP-MYE-ACUP-001 | Other Identifier | Atrium Health |
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Low accrual
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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This randomized, controlled trial is designed to evaluate the effect of acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN), other symptoms, and potential opioid and concomitant medication sparing effects in comparison to standard of care management in Multiple Myeloma subjects.
This study aims to strengthen the care of persons with Multiple Myeloma by improving quality of life (QOL) and ability to perform daily activities through reduced Chemotherapy-Induced Peripheral Neuropathy (CIPN) symptoms. CIPN debilitates and erodes QOL by preventing individuals from pursuing their normal activities of daily living.
The features of CIPN, including physical, social/family, emotional, functional, and specific CIPN symptoms, will be measured with the validated FACT-GOG-NTX. This project brings necessary attention and scientific inquiry to supportive cancer care, which is sometimes de-prioritized behind disease treatment. The potential for nonpharmacologic acupuncture to reduce CIPN and other symptoms with minimal side effects has beneficial implications for disease treatment. Patients with controlled symptoms are better able to tolerate life-prolonging treatment and avoid chemotherapy dose reductions which result from neurotoxic side effects of chemotherapy.
Subjects who consent and are determined to be eligible will be randomized to receive either acupuncture treatment or standard of care treatment for their CIPN. Subjects' socio-demographics, medical history, opioid and concomitant medication intake information will be collected. Subjects who are randomized to the acupuncture treatment arm will receive 12 sessions of acupuncture over approximately 10 weeks. Subjects randomized to standard of care will continue with standard of care therapy per their physician for treatment of their CIPN. All subjects will complete questionnaires at Baseline, mid-point, and endpoint. Responses to questionnaires will then be analyzed towards answering the study's objectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Subjects on this arm will receive 12 sessions of acupuncture over approximately 10 weeks, along with continued standard treatment by their physician. |
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| Standard of Care | Active Comparator | Subjects on this arm will not receive acupuncture, but will continue to be followed by their physician with standard treatment for their neuropathy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | 12 acupuncture sessions over 10 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management. | Neuropathy will be subject reported using an 11-point scale from 0-no neuropathy to 10-worst possible neuropathy. The outcome will be measured as a binary variable indicating whether or not a subject experienced at least a 2-point improvement in neuropathy between the baseline score and the score obtained at Week 10 +/- 1 week. | Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure. |
| Measure | Description | Time Frame |
|---|---|---|
| Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX | Specific features of CIPN assessed through the subscale from FACT-GOG-NTX will be determined for each subject as a composite measure, which is calculated as the sum of the responses to the subscale questions. For subjects who complete all 12 subscale questions, the composite score will range from 0 to 48. Higher scores mean worse outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events of Special Interest | Adverse Events of Special Interest (AESI) will be determined for each subject as binary variables indicating whether or not they experienced a protocol defined AESI, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, or dizziness, syncope, fatigue, or hyperhidrosis. | approx. 10 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shamille Hariharan, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | Acupuncture: 12 acupuncture sessions over 10 weeks |
| FG001 | Standard of Care | Standard of Care CIPN management: Investigator directed standard of care management of CIPN |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | Acupuncture: 12 acupuncture sessions over 10 weeks |
| BG001 | Standard of Care | Standard of Care CIPN management: Investigator directed standard of care management of CIPN |
| Units | Counts |
|---|---|
| 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 | Median |
| 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 | Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management. | Neuropathy will be subject reported using an 11-point scale from 0-no neuropathy to 10-worst possible neuropathy. The outcome will be measured as a binary variable indicating whether or not a subject experienced at least a 2-point improvement in neuropathy between the baseline score and the score obtained at Week 10 +/- 1 week. | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure. |
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AESIs were collected for approximately 10 weeks for the duration of the acupuncture treatment (for those on the intervention arm) and collected through 30 days after last acupuncture session. Serious adverse events and all-cause mortality were monitored and collected for both arms throughout the study, approximately 10 weeks.
Only All-Cause Mortality, Serious Adverse Events, and Adverse Events of Special Interest (AESI) were collected for this study. All-cause mortality and Serious Adverse Events were collected for both arms as defined in the clinicaltrials.gov definition. AESIs were collected only for subjects on the intervention arm, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, dizziness, syncope, fatigue, or hyperhidrosis.
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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 | Acupuncture | Acupuncture: 12 acupuncture sessions over 10 weeks | 0 |
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Early termination due to low accrual leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chair of Biostatistics Department | Atrium Health Levine Cancer | 9804422371 | james.symanowski@atriumhealth.org |
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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 | Apr 21, 2023 | Mar 28, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 13, 2023 | Aug 22, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Standard of Care CIPN management |
| Other |
Investigator directed standard of care management of CIPN |
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| 10 weeks |
| Nausea - FACT-GOG-NTX | Nausea will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP2 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have nausea.' | approx. 10 weeks |
| Sadness- FACT-GOG-NTX | Sadness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel sad'. | approx. 10 weeks |
| Nervousness- FACT-GOG-NTX | Nervousness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel nervous.' | approx. 10 weeks |
| Sleep Quality- FACT-GOG-NTX | Sleep quality will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GF5 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I am sleeping well.' | approx. 10 weeks |
| Lack of Energy- FACT-GOG-NTX | Lack of energy will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have a lack of energy.' | approx. 10 weeks |
| Pain- FACT-GOG-NTX | Pain will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have pain.' | approx. 10 weeks |
| Constipation | Constipation will be determined for each subject as a 5-level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have constipation.' | approx. 10 weeks |
| Dizziness | Dizziness will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dizziness'. | approx. 10 weeks |
| Dry Mouth | Dry mouth will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dry mouth.' | approx. 10 weeks |
| General Health - CDC-HRQOL | General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent. | approx. 10 weeks |
| Opioid Use | Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD). | approx. 10 weeks |
| Acupuncture Administration | Acupuncture administration will be defined for each subject on the acupuncture arm as the number of attended acupuncture sessions from 0 to 12. | approx. 10 weeks |
| Acupuncture Expectancy | The acupuncture expectancy score will be captured quantitatively for each subject as a composite score ranging from 4 to 20. Higher scores indicate higher expectancy of acupuncture. | approx 10 weeks |
| Withdrawal by Subject |
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| BG002 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
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| Baseline Chemotherapy-Induced Peripheral Neuropathy Score | Neuropathy is subject reported using an 11-point scale from 0-no neuropathy to 10-worst possible neuropathy. | Count of Participants | Participants |
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| OG001 | Standard of Care | Standard of Care CIPN management: Investigator directed standard of care management of CIPN |
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| Secondary | Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX | Specific features of CIPN assessed through the subscale from FACT-GOG-NTX will be determined for each subject as a composite measure, which is calculated as the sum of the responses to the subscale questions. For subjects who complete all 12 subscale questions, the composite score will range from 0 to 48. Higher scores mean worse outcome | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Median | Full Range | Score on a scale | 10 weeks |
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| Secondary | Nausea - FACT-GOG-NTX | Nausea will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP2 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have nausea.' | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | Sadness- FACT-GOG-NTX | Sadness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel sad'. | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | Nervousness- FACT-GOG-NTX | Nervousness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel nervous.' | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | Sleep Quality- FACT-GOG-NTX | Sleep quality will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GF5 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I am sleeping well.' | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | Lack of Energy- FACT-GOG-NTX | Lack of energy will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have a lack of energy.' | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | Pain- FACT-GOG-NTX | Pain will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have pain.' | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | Constipation | Constipation will be determined for each subject as a 5-level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have constipation.' | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | Dizziness | Dizziness will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dizziness'. | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | Dry Mouth | Dry mouth will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dry mouth.' | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Secondary | General Health - CDC-HRQOL | General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent. | The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores. | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Other Pre-specified | Adverse Events of Special Interest | Adverse Events of Special Interest (AESI) will be determined for each subject as binary variables indicating whether or not they experienced a protocol defined AESI, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, or dizziness, syncope, fatigue, or hyperhidrosis. | Enrolled participants on the acupuncture arm | Posted | Count of Participants | Participants | approx. 10 weeks |
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| Other Pre-specified | Opioid Use | Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD). | All participants receiving acupuncture or standard of care | Posted | Median | Full Range | morphine milligram equivalents per day | approx. 10 weeks |
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| Other Pre-specified | Acupuncture Administration | Acupuncture administration will be defined for each subject on the acupuncture arm as the number of attended acupuncture sessions from 0 to 12. | Enrolled participants randomized to the acupuncture arm | Posted | Median | Full Range | number of acupuncture sessions | approx. 10 weeks |
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| Other Pre-specified | Acupuncture Expectancy | The acupuncture expectancy score will be captured quantitatively for each subject as a composite score ranging from 4 to 20. Higher scores indicate higher expectancy of acupuncture. | Participants randomized to the acupuncture arm | Posted | Median | Full Range | Score on a scale | approx 10 weeks |
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| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Standard of Care | Standard of Care CIPN management: Investigator directed standard of care management of CIPN | 0 | 4 | 0 | 4 | 0 | 0 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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