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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00917 | Registry Identifier | NCI CTRP |
Not provided
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Per PI
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| Name | Class |
|---|---|
| Healios Oncology Nutrition | OTHER |
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The goal of this clinical research study is to learn if glutamine can help control and prevent sores, blisters, or inflammation in your mouth or esophagus due to your current treatment.
In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks like the drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:
Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Study Drug Administration:
Glutamine or the placebo will be taken as a sugary drink by mouth. You will take the drink twice daily starting the day you first receive your anti-cancer therapy or radiation treatment.
You will mix one scoop of powder with 25-100 milliliters (about 2-6 tablespoons) of water. If you are in the chemotherapy group, you will swish the drink for 10 seconds and swallow. If you are in the radiation group, you will swallow the drink in small amounts several times.
Study Visits:
At every visit, you will be asked about any side effects you may be having and about any other drugs you may be taking.
Chemotherapy Group:
On Days 1, 8, and 22 of Cycle 1:
On Day 15 of Cycle 1:
On Day 1 of Cycle 2 and beyond:
After 3 months of chemotherapy:
After 6 months of chemotherapy:
Follow-Up:
For your follow-up questionnaires at Day 1 of every Cycle, at 3 and 6 months, and during the End-of-Study visit, you may be called by the study team. This call should last about 5-10 minutes.
Radiation Therapy Group:
On Weeks 1, 2, 4, and 6 of Radiation:
On Weeks 3 and 5 of Radiation:
On Week 7 of Radiation:
You will be asked if you have inflammation of your esophagus.
Your weight will be recorded.
If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
You will complete a quality of life questionnaire.
You will complete a survey about how you feel about the study drug.
1 month after your radiation has ended:
You will be asked if you have inflammation of your esophagus.
Your weight will be recorded.
If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for routine tests.
You will complete a quality of life questionnaire.
You will complete a survey about how you feel about the study drug.
3 months after your radiation has ended:
You will complete a quality of life questionnaire.
Follow-Up:
For your follow-up questionnaires at 1 and 3 months and during the End-of-Study visit, you may be called by the study team. This call should last about 5-10 minutes.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest.
You will continue taking the glutamine or placebo for 4 weeks after the completion of your anti-cancer therapy or radiation treatment. If you stop chemotherapy or radiation before completion of the intended study period, you will continue to take the study drug for 4 weeks.
If you develop severe sores, blisters, or inflammation in your mouth or esophagus, you will be removed from the study, and the doctor will give you another medication for your sores and blisters.
Your participation on the study will be over 6 months after completion of your therapy.
End-of-Study Visit:
After you are off study, you will have an end-of-study visit. For the radiation group, this will be 6 months after radiation therapy. For the chemotherapy group, this is 4 weeks after the last dose.
This is an investigational study. Glutamine is FDA approved and commercially available for the treatment of short bowel syndrome. Its use to treat mouth sores and inflammation of the esophagus is investigational.
Up to 180 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mTOR Inhibitor Patient Group - Placebo | Placebo Comparator | Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. |
|
| mTOR Inhibitor Patient Group - Glutamine | Experimental | Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. |
|
| Radiation Therapy to Esophagus Patient Group - Placebo | Placebo Comparator | Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. |
|
| Radiation Therapy to Esophagus Patient Group - Glutamine | Experimental | Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | mTOR Inhibitor Patient Group: Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Esophagitis for Radiation Therapy Patients | For esophagus radiation participants, the severity of esophagitis will be taken as the highest grade observed by week six. Wilcoxon rank sum test used to compare the ordered categories of esophagitis severity. | 6 weeks |
| Severity of Oral Mucositis for mTOR Inhibitor Patients | For mTOR inhibitor patients, the severity of oral mucositis will be taken as the maximum grade observed during the 6-month study period. Wilcoxon rank sum test used to compare the ordered categories of mucositis severity. | 6 months after start of mTOR inhibitor based treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) in Esophagus Radiation Patients at Baseline | The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1) Patients currently receiving therapy for mucositis.
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| Name | Affiliation | Role |
|---|---|---|
| Aung Naing, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33580845 | Derived | Alshawa A, Cadena AP, Stephen B, Reddy A, Mendoza TR, McQuinn L, Lawhorn K, Zarifa A, Bernhardt AM, Fessaheye S, Warneke CL, Chang JY, Naing A. Effects of glutamine for prevention of radiation-induced esophagitis: a double-blind placebo-controlled trial. Invest New Drugs. 2021 Aug;39(4):1113-1122. doi: 10.1007/s10637-021-01074-w. Epub 2021 Feb 13. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
The mTOR inhibitor cohort 24 patients consented. 10 enrolled patients became ineligible after consent and before randomization due to changes in their treatment plan. The radiation cohort enrolled 53 patients; 27 were randomized to the glutamine arm and 26 were randomized to the placebo arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy to Esophagus Patient Group - Glutamine | Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit. |
| FG001 | Radiation Therapy to Esophagus Patient Group - Placebo | Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit. |
| FG002 | mTOR Inhibitor Patient Group - Glutamine | Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit. |
| FG003 | mTOR Inhibitor Patient Group - Placebo | Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data were unavailable for 1 participant who withdrew consent after randomization but before treatment start in mTOR Inhibitor Patient Group-Placebo
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy to Esophagus Patient Group - Glutamine | Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Severity of Esophagitis for Radiation Therapy Patients | For esophagus radiation participants, the severity of esophagitis will be taken as the highest grade observed by week six. Wilcoxon rank sum test used to compare the ordered categories of esophagitis severity. | Participants who took at least 60% of the planned doses of the study treatment and were evaluable per protocol definition. | Posted | Count of Participants | Participants | 6 weeks |
|
From the first dose through end of the study. Up to approximately 6 months post the radiation for the radiation therapy group. Up to 3 months, 6 months post last dose of mTOR inhibitor therapy (approximately 12 months study duration) for the mTOR inhibitor group.
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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 | Radiation Therapy to Esophagus Patient Group - Glutamine | Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aung Naing, MD-Professor, Invest. Cancer Therapeutics | UT MD Anderson Cancer Center | (713) 563-3885 | anaing@mdanderson.org |
Not provided
| 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 | Aug 28, 2019 | Feb 23, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D052016 | Mucositis |
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005973 | Glutamine |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
Not provided
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Not provided
Not provided
Not provided
Not provided
|
|
| Glutamine | Drug | mTOR Inhibitor Patient Group - Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. |
|
| Questionnaires | Behavioral | Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit. |
|
| at baseline |
| Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline | The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden. | at baseline |
| Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start | Participants in each arm received at least 60% of planned doses of the study drug (glutamine or placebo). | 6 weeks |
| Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start | 6 months |
| Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start | 6 weeks |
| Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start | 6 month |
| Duration of Esophagitis After Radiation Treatment Start | From event starts to end of study visit |
| Duration of Mucositis After mTOR Inhibitor Treatment Start | From event starts to end of study visit |
| Time to Esophagitis on the Radiation Cohort Onset | From radiation starts to end of study visit |
| Proportion of Participants Who Were Mucositis-Free at 18.3 Weeks | Proportion of participants who were free of Mucositis at 18.3 weeks.. | 18.3 weeks |
| Number of Participants With Cancer Treatment Interruptions Due to Esophagitis | From radiation treatment start to end of study visit, approximately 6 months |
| Number of Participants With Cancer Treatment Interruptions Due to Mucositis | 6 months after start of mTOR inhibitor based treatment |
| Radiation Cohort Participant Weight Change From Baseline to End of Study | Investigators recorded weight at baseline to the end of treatment with glutamine/placebo. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test. | from baseline to 6 months post radiation therapy |
| mTOR Inhibitor Cohort Participant Weight Change From Baseline to End of Study | Investigators recorded the weight at baseline and the end of the study. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test. | baseline, weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor |
| Summary of Adverse Events by Grade and Relationship - Radiation Cohort | CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo. | weekly during radiation, 1 month and 6 months post radiation therapy until resolution, stabilization, death, loss to follow up, or commencement of new therapy |
| Summary of Adverse Events by Grade and Relationship - mTOR Inhibitor Cohort | CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo | weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor until resolution, stabilization, death, loss to follow up, or commencement of new therapy |
| Lack of Insurance Coverage |
|
| Withdrawal by Subject |
|
| BG001 | Radiation Therapy to Esophagus Patient Group - Placebo | Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit. |
| BG002 | mTOR Inhibitor Patient Group - Glutamine | Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit. |
| BG003 | mTOR Inhibitor Patient Group - Placebo | Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cancer Type | Count of Participants | Participants |
|
| BMI | Height not available for mTOR cohort | no data for BMI taken for the mTOR cohort | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Radiation Therapy to Esophagus Patient Group - Placebo | Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit. |
|
|
|
| Primary | Severity of Oral Mucositis for mTOR Inhibitor Patients | For mTOR inhibitor patients, the severity of oral mucositis will be taken as the maximum grade observed during the 6-month study period. Wilcoxon rank sum test used to compare the ordered categories of mucositis severity. | Evaluable Participants in the mTOR Inhibitor Cohort | Posted | Count of Participants | Participants | 6 months after start of mTOR inhibitor based treatment |
|
|
|
|
| Secondary | Quality of Life (QOL) in Esophagus Radiation Patients at Baseline | The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden. | Posted | Median | Full Range | score on a scale | at baseline |
|
|
|
| Secondary | Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline | The Quality of Life assessed by the MD Anderson Symptom Inventory for head and neck cancer (MDASI-HN). The 13 Core symptoms include dry mouth, fatigue, pain, disturbed sleep, drowsiness, feeling of being distressed, anorexia, sadness, numbness/tingling, dyspnea, difficulty remembering, nausea, and vomiting. The 9 Head and Neck symptoms include mouth sores, problems with taste, constipation, teeth/gum problems, skin pain, difficulty with voice, choking/coughing, difficulty swallowing, and problems with mucus specific to head and neck cancers. Total symptom severity include 24 core and Head and Neck symptoms together. Symptom interference asks patients about how their symptoms impact their daily functions. The severity of each symptom and symptom interference is rated on a numerical scale from 0 (symptom is absent) to 10 (worst possible severity)." Higher scores indicate a greater symptom burden. | Posted | Median | Full Range | score on a scale | at baseline |
|
|
|
| Secondary | Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start | Participants in each arm received at least 60% of planned doses of the study drug (glutamine or placebo). | Evaluable participant | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| Secondary | Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| Secondary | Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start | Posted | Count of Participants | Participants | 6 month |
|
|
|
|
| Secondary | Duration of Esophagitis After Radiation Treatment Start | Participants in the radiation cohort who experienced esophagitis. | Posted | Median | Inter-Quartile Range | weeks | From event starts to end of study visit |
|
|
|
|
| Secondary | Duration of Mucositis After mTOR Inhibitor Treatment Start | Participants in the mTOR cohort who experienced mucositis. | Posted | Median | Inter-Quartile Range | weeks | From event starts to end of study visit |
|
|
|
|
| Secondary | Time to Esophagitis on the Radiation Cohort Onset | Posted | Median | 95% Confidence Interval | weeks | From radiation starts to end of study visit |
|
|
|
|
| Secondary | Proportion of Participants Who Were Mucositis-Free at 18.3 Weeks | Proportion of participants who were free of Mucositis at 18.3 weeks.. | Posted | Number | 95% Confidence Interval | percentage of participants | 18.3 weeks |
|
|
|
| Secondary | Number of Participants With Cancer Treatment Interruptions Due to Esophagitis | Posted | Count of Participants | Participants | From radiation treatment start to end of study visit, approximately 6 months |
|
|
|
| Secondary | Number of Participants With Cancer Treatment Interruptions Due to Mucositis | Posted | Count of Participants | Participants | 6 months after start of mTOR inhibitor based treatment |
|
|
|
| Secondary | Radiation Cohort Participant Weight Change From Baseline to End of Study | Investigators recorded weight at baseline to the end of treatment with glutamine/placebo. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test. | Posted | Median | Inter-Quartile Range | kg | from baseline to 6 months post radiation therapy |
|
|
|
|
| Secondary | mTOR Inhibitor Cohort Participant Weight Change From Baseline to End of Study | Investigators recorded the weight at baseline and the end of the study. Weight loss calculated at each study assessment visit using the Wilcoxon rank sum test. | Posted | Median | Inter-Quartile Range | kg | baseline, weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor |
|
|
|
|
| Secondary | Summary of Adverse Events by Grade and Relationship - Radiation Cohort | CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo. | Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo. | Posted | Number | adverse events | weekly during radiation, 1 month and 6 months post radiation therapy until resolution, stabilization, death, loss to follow up, or commencement of new therapy |
|
|
|
| Secondary | Summary of Adverse Events by Grade and Relationship - mTOR Inhibitor Cohort | CTCAE version 4.03 used to access the adverse events. Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated Grade 3 Severely altered eating/swallowing; tube feeding, TPN or hospitalization indicated. Total toxicity-evaluable is the total number of participants who had at least one dose of glutamine or placebo | Posted | Number | adverse events | weekly during Cycle 1, and Day 1 of Cycle 2 and beyond, and 4 weeks and 6 months after the last dose of the mTOR inhibitor until resolution, stabilization, death, loss to follow up, or commencement of new therapy |
|
|
|
| 6 |
| 25 |
| 5 |
| 25 |
| 20 |
| 25 |
| EG001 | Radiation Therapy to Esophagus Patient Group - Placebo | Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times. Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit. | 2 | 24 | 3 | 24 | 15 | 24 |
| EG002 | mTOR Inhibitor Patient Group - Glutamine | Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit. | 0 | 7 | 1 | 7 | 5 | 7 |
| EG003 | mTOR Inhibitor Patient Group - Placebo | Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy. Questionnaires: Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit. | 0 | 6 | 2 | 6 | 6 | 6 |
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE version 4.03 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Pulmonary hypretension | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorder | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4.03 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE version 4.03 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Odynophagia | General disorders | CTCAE version 4.03 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
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| Rash,Maculopapular | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE version 4.03 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE version 4.03 | Systematic Assessment |
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| Weight loss | Investigations | CTCAE version 4.03 | Systematic Assessment |
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Not provided
Not provided
Not provided
| D009057 |
| Stomatognathic Diseases |
| D004935 | Esophageal Diseases |
| D021542 | Amino Acids, Neutral |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Grade 3 |
|
| Absent |
|
| Head & Neck symptom Severity |
|
| Symptom Interference Severity |
|
| Head & Neck symptom severity |
|
| Symptom Interference severity |
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| Grade 2 Possibly related |
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| Grade 2 Unlikely related |
|
| Grade 2 Unrelated |
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| Grade 1 Possibly related |
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| Grade 1 Unlikely related |
|
| Grade 1 Unrelated |
|
| Grade 1 Unrelated |
|