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Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01952847
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Healios Oncology Nutrition
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
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 : July 2014
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Surveys




Primary Outcome Measures :
  1. Severity of Oral Mucositis for mTOR Inhibitor Patients [ Time Frame: 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.

  2. Severity of Esophagitis for Radiation Therapy Patients [ Time Frame: 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 :
  1. Quality of Life (QOL) in mTOR Inhibitor Patients [ Time Frame: 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

  2. Quality of Life (QOL) in Esophagus Radiation Patients [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952847


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Healios Oncology Nutrition
Investigators
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Principal Investigator: Aung Naing, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01952847     History of Changes
Other Study ID Numbers: 2013-0308
NCI-2014-00917 ( Registry Identifier: NCI CTRP )
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
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
Additional relevant MeSH terms:
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Mucositis
Esophagitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Esophageal Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents