Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis

Advanced Cancers Clinical Trial

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

Status Terminated

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Advanced Cancers
• Esophagitis
• Mucositis

• NCT number: NCT01952847
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 3
• Start date: July 10, 2014
• Completion date: March 3, 2021