Advanced CancersPhase 3NCT01952847
Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis
A Phase 3 study testing Glutamine and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Glutamine and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2014to 3 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who will be initiating therapy with any investigator-initiated mTOR inhibitor based therapy in the Department of Investigational Cancer Therapeutics (Phase I Program) or initiating radiation therapy to the esophagus.
- For the esophagitis arm, any patient with thoracic malignancies, which will receive radiation alone or concurrent chemo/radiation. Radiation dose must be >/= 45 Gy. For the esophagitis arm, induction chemotherapy is allowed.
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- Patients must be >/= 17 years of age.
- Females of childbearing potential must have a negative pregnancy test. Sexually active patients must agree to use contraception prior to, during, and 30 days after last dose.
Who cannot join
- 1) Patients currently receiving therapy for mucositis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized, Double Blinded Placebo-Controlled Study of Glutamine in Patients With Oral Mucositis on an mTOR Inhibitor-based Regimen or Esophagitis on a Regimen Receiving Radiation to the Esophagus
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.
Read the detailed description
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:
- If you are in Group 1, you will receive glutamine.
- If you are in Group 2, you will receive a placebo.
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:
- You will have a mouth exam.
- Your weight will be recorded.
On Day 15 of Cycle 1:
- You will have a mouth exam.
- Your weight will be recorded.
- You will complete a quality of life questionnaire.
On Day 1 of Cycle 2 and beyond:
- You will have a mouth exam.
- 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. This should take about 5-10 minutes to complete.
- If the doctor thinks it is needed, you will have a photograph of your mouth taken.
After 3 months of chemotherapy:
- You will complete a quality of life questionnaire.
After 6 months of chemotherapy:
- Your weight will be recorded.
- You will complete a quality of life questionnaire.
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:
- 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.
On Weeks 3 and 5 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.
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.
- 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.
- If you are in the chemotherapy group, you will have a mouth exam.
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.
- Conditions
- Advanced Cancers
- Being tested
- Placebo, Glutamine, Questionnaires
- Keywords
- Advanced Cancers, Mucositis, Esophagitis, mTOR Inhibitor-based Regimen, Radiation to the Esophagus, Thoracic malignancies, Placebo, Glutamine, Enterex, Glutapak-10, NutreStore, Resource, GlutaSolve, Sympt-X G.I., Sympt-X, Questionnaires, Surveys
- Medical subject headings
- Mucositis, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
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.
GlutamineDrug
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.
QuestionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Placebo; Behavioral: Questionnaires |
| 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. Receives: Drug: Glutamine; Behavioral: Questionnaires |
| 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. Receives: Other: Placebo; Behavioral: Questionnaires |
| 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. Receives: Drug: Glutamine; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months after start of mTOR inhibitor based treatment
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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).
Measured: 6 weeks
Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start
Measured: 6 months
Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start
Measured: 6 weeks
Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start
Measured: 6 month
Duration of Esophagitis After Radiation Treatment Start
Measured: From event starts to end of study visit
Duration of Mucositis After mTOR Inhibitor Treatment Start
Measured: From event starts to end of study visit
Time to Esophagitis on the Radiation Cohort Onset
Measured: 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..
Measured: 18.3 weeks
Number of Participants With Cancer Treatment Interruptions Due to Esophagitis
Measured: From radiation treatment start to end of study visit, approximately 6 months
Number of Participants With Cancer Treatment Interruptions Due to Mucositis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study start10 Jul 2014
- Primary completion3 Mar 2021
- Study completion3 Mar 2021
Why it stopped: Per PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Healios Oncology Nutrition
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952847
- Sponsor's protocol ID
- 2013-0308
- Other IDs
- NCI-2014-00917
- Status last verified
- Jun 2022
- First submitted
- 24 Sep 2013
- Last updated
- 15 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33580845
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blinded Placebo-Controlled Study of Glutamine in Patients With Oral Mucositis on an mTOR Inhibitor-based Regimen or Esophagitis on a Regimen Receiving Radiation to the Esophagus
- ClinicalTrials.gov ID
- NCT01952847
- Acronym / sponsor ID
- 2013-0308
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Mucositis, Esophagitis, mTOR Inhibitor-based Regimen, Radiation to the Esophagus, Thoracic malignancies, Placebo, Glutamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per PI
- Enrolment
- 77 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Healios Oncology Nutrition
- Study start
- 10 Jul 2014 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 15 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- If you are in Group 1, you will receive glutamine.
- If you are in Group 2, you will receive a placebo.
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:
- You will have a mouth exam.
- Your weight will be recorded.
On Day 15 of Cycle 1:
- You will have a mouth exam.
- Your weight will be recorded.
- You will complete a quality of life questionnaire.
On Day 1 of Cycle 2 and beyond:
- You will have a mouth exam.
- 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. This should take about 5-10 minutes to complete.
- If the doctor thinks it is needed, you will have a photograph of your mouth taken.
After 3 months of chemotherapy:
- You will complete a quality of life questionnaire.
After 6 months of chemotherapy:
- Your weight will be recorded.
- You will complete a quality of life questionnaire.
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:
- 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.
On Weeks 3 and 5 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.
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.
- 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.
- If you are in the chemotherapy group, you will have a mouth exam.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mTOR Inhibitor Patient Group - Placebo | Placebo comparator | Other: Placebo, Behavioral: QuestionnairesParticipants 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 | Drug: Glutamine, Behavioral: QuestionnairesGlutamine 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 | Other: Placebo, Behavioral: QuestionnairesPlacebo 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 | Drug: Glutamine, Behavioral: QuestionnairesGlutamine 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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who will be initiating therapy with any investigator-initiated mTOR inhibitor based therapy in the Department of Investigational Cancer Therapeutics (Phase I Program) or initiating radiation therapy to the esophagus.
- For the esophagitis arm, any patient with thoracic malignancies, which will receive radiation alone or concurrent chemo/radiation. Radiation dose must be >/= 45 Gy. For the esophagitis arm, induction chemotherapy is allowed.
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- Patients must be >/= 17 years of age.
- Females of childbearing potential must have a negative pregnancy test. Sexually active patients must agree to use contraception prior to, during, and 30 days after last dose.
Key exclusion criteria (1 listed)
- 1) Patients currently receiving therapy for mucositis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlacebomTOR 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. | Other | Radiation Therapy to Esophagus Patient Group - Placebo, mTOR Inhibitor Patient Group - Placebo |
| GlutaminemTOR 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. | Drug | Radiation Therapy to Esophagus Patient Group - Glutamine, mTOR Inhibitor Patient Group - Glutamine |
| QuestionnairesQuestionnaire 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. | Behavioural | Radiation Therapy to Esophagus Patient Group - Glutamine, Radiation Therapy to Esophagus Patient Group - Placebo, mTOR Inhibitor Patient Group - Glutamine, mTOR Inhibitor Patient Group - Placebo |
Primary outcome
Severity of Esophagitis for Radiation Therapy Patients
Time frame: 6 weeks
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.
Severity of Oral Mucositis for mTOR Inhibitor Patients
Time frame: 6 months after start of mTOR inhibitor based treatment
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.
16 secondary outcomes
Quality of Life (QOL) in Esophagus Radiation Patients at Baseline
Time frame: at baseline
Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline
Time frame: at baseline
Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start
Time frame: 6 weeks
Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start
Time frame: 6 months
Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start
Time frame: 6 weeks
Grade 3 or Higher Mucositis Incidence Per Participant During 6 Months After Treatment Start
Time frame: 6 month
Duration of Esophagitis After Radiation Treatment Start
Time frame: From event starts to end of study visit
Duration of Mucositis After mTOR Inhibitor Treatment Start
Time frame: From event starts to end of study visit
Time to Esophagitis on the Radiation Cohort Onset
Time frame: From radiation starts to end of study visit
Proportion of Participants Who Were Mucositis-Free at 18.3 Weeks
Time frame: 18.3 weeks
Number of Participants With Cancer Treatment Interruptions Due to Esophagitis
Time frame: From radiation treatment start to end of study visit, approximately 6 months
Number of Participants With Cancer Treatment Interruptions Due to Mucositis
Time frame: 6 months after start of mTOR inhibitor based treatment
Radiation Cohort Participant Weight Change From Baseline to End of Study
Time frame: from baseline to 6 months post radiation therapy
mTOR Inhibitor Cohort Participant Weight Change From Baseline to End of Study
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33580845Alshawa 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aung Naing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glutamine and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Esophagitis for Radiation Therapy Patients (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.