Ignite Creation Date:
2024-05-06 @ 2:02 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01952847
Status:
TERMINATED
Last Update Posted:
2022-06-15
First Post:
2013-09-24
Brief Title:
Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-00917 | REGISTRY | NCI CTRP | None |