Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis

NCT01952847 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2013-0308NCI-2014-00917
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancers

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Severity of Esophagitis for Radiation Therapy Patients

  For esophagus radiation participants, 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.

  6 weeks

• Severity of Oral Mucositis for mTOR Inhibitor Patients

  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.

  6 months after start of mTOR inhibitor based treatment

Secondary Outcomes (16)

• Quality of Life (QOL) in Esophagus Radiation Patients at Baseline

  at baseline

• Quality of Life (QOL) in mTOR Inhibitor Patients at Baseline

  at baseline

• Number of Participants With Esophagitis During 6 Weeks After Radiation Treatment Start

  6 weeks

• Mucositis Incidence Per Participant During 6 Months After mTOR Inhibitor Treatment Start

  6 months

• Grade 3 or Higher Esophagitis Incidence Per Participant During 6 Weeks After Radiation Start

  6 weeks

Study Arms (4)

mTOR Inhibitor Patient Group - Placebo

PLACEBO COMPARATOR

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; Behavioral: Questionnaires

mTOR Inhibitor Patient Group - Glutamine

EXPERIMENTAL

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; Behavioral: Questionnaires

Radiation Therapy to Esophagus Patient Group - Placebo

PLACEBO COMPARATOR

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; Behavioral: Questionnaires

Radiation Therapy to Esophagus Patient Group - Glutamine

EXPERIMENTAL

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; Behavioral: Questionnaires

Interventions

Placebo OTHER

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; mTOR Inhibitor Patient Group - Placebo

Glutamine DRUG

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; mTOR Inhibitor Patient Group - Glutamine

Questionnaires BEHAVIORAL

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.

Radiation Therapy to Esophagus Patient Group - Glutamine; Radiation Therapy to Esophagus Patient Group - Placebo; mTOR Inhibitor Patient Group - Glutamine; mTOR Inhibitor Patient Group - Placebo

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) Patients currently receiving therapy for mucositis.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Healios Oncology Nutrition: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Alshawa A, Cadena AP, Stephen B, Reddy A, Mendoza TR, McQuinn L, Lawhorn K, Zarifa A, Bernhardt AM, Fessaheye S, Warneke CL, Chang JY, Naing A. Effects of glutamine for prevention of radiation-induced esophagitis: a double-blind placebo-controlled trial. Invest New Drugs. 2021 Aug;39(4):1113-1122. doi: 10.1007/s10637-021-01074-w. Epub 2021 Feb 13.

  PMID: 33580845 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Mucositis; Esophagitis

Interventions

Glutamine; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Aung Naing, MD-Professor, Invest. Cancer Therapeutics
• Organization: UT MD Anderson Cancer Center

anaing@mdanderson.org

(713) 563-3885

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 30, 2013
• Study Start: July 10, 2014
• Primary Completion: March 3, 2021
• Study Completion: March 3, 2021
• Last Updated: June 15, 2022
• Results First Posted: June 15, 2022

Record last verified: 2022-06

Locations

US (1)