Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 17 - Any |
| Updated: | 4/29/2018 |
| Start Date: | July 2014 |
| End Date: | July 2020 |
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.
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:
- 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.
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.
Inclusion Criteria:
1. 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.
2. 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.
3. 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.
4. Patients must be >/= 17 years of age.
5. 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.
Exclusion Criteria:
1) Patients currently receiving therapy for mucositis.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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