Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01952847

Collaborator

Healios Oncology Nutrition (Other)

Enrollment

Location

Arms

79.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancers	Other: Placebo Drug: Glutamine Behavioral: Questionnaires	Phase 3

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

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jul 10, 2014

Actual Primary Completion Date :

Mar 3, 2021

Actual Study Completion Date :

Mar 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Other: Placebo 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. Radiation Therapy to Esophagus Patient Group - 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. Behavioral: 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. 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. Other Names: Surveys
Experimental: 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.	Drug: Glutamine 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. Radiation Therapy to Esophagus Patient Group - 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. Behavioral: 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. 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. Other Names: Surveys
Placebo Comparator: 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.	Other: Placebo 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. Radiation Therapy to Esophagus Patient Group - 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. Behavioral: 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. 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. Other Names: Surveys
Experimental: 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.	Drug: Glutamine 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. Radiation Therapy to Esophagus Patient Group - 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. Behavioral: 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. 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. Other Names: Surveys

Outcome Measures

Primary Outcome Measures

Severity of Oral Mucositis for mTOR Inhibitor Patients [6 months]
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.
Severity of Esophagitis for Radiation Therapy Patients [6 weeks]
For esophagus radiation patients, 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.

Secondary Outcome Measures

Quality of Life (QOL) in mTOR Inhibitor Patients [Baseline, Day 15 of Cycle 1, Day 1 of Cycles 2 and beyond until end of treatment with drug, and 3 months and 6 months post end of treatment]
QOL assessed by MDASI-HN
Quality of Life (QOL) in Esophagus Radiation Patients [Baseline, Weeks 3, 5, and 7 of radiation to end of radiation treatment (or final week of radiation treatment based on number of weeks of radiation), 1 month, 3 months, and 6 months post radiation therapy]
QOL assessed by MDASI-HN

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.