Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

NCT02012608 | Terminated Phase 2 Results DMC

• 1 other identifier: 202253
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-centered, double-blind, two-arm randomized study to determine if oral glutamine will reduce radiation toxicity for the subjects undergoing Breast Conserving Therapy.

Conditions

Breast Cancer

Keywords

breast

Outcome Measures

Primary Outcomes (1)

• Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria

  The primary efficacy outcome will be excessive toxicity, which will be defined as a score of 2 or higher using the Radiation Therapy Oncology Group (RTOG) Acute scale of radiation-toxicity criteria when scored on either the 12-day or 30-day assessment time. The RTOG scale ranges from 0-4 with 0 being defined as "no change".

  12 days and 30 days

Study Arms (2)

Glutamine

ACTIVE COMPARATOR

Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day

Drug: Glutamine

Placebo

PLACEBO COMPARATOR

Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day

Drug: Placebo

Interventions

Glutamine DRUG

Oral glutamine for subjects undergoing breast conserving therapy

Also known as: Gln, Q

Glutamine

Placebo DRUG

For subjects undergoing breast conserving therapy

Also known as: Dextrose, Dextrose monohydrate, Sugar

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject have been diagnosed with Stage I or II invasive breast cancer
• Subject will undergo Accelerated Partial Breast Irradiation (APBI) as part of Breast Conserving Therapy (BCT)
• Subject is eligible for APBI based on American Society of Therapeutic Radiation Oncology (ASTRO) criteria
• Subject is 18 years of age or older
• Subject is female

You may not qualify if:

• History of uncontrolled, clinically significant lung, heart, endocrine, liver, or renal disease
• Subject has been diagnosed with any other cancer
• Subject has a known hypersensitivity reaction to the following: oral glutamine (GLN), glutamate, monosodium glutamate (MSG) (i.e., Chinese restaurant syndrome)
• Subject has history of collagen vascular disease
• Subject has been diagnosed with Diabetes mellitus I or II
• Subject has had any prior breast radiation
• Subject is pregnant or breastfeeding

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Glutamine; Glucose; Sugars

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Hexoses; Monosaccharides; Carbohydrates

Limitations and Caveats

Outcome measures not computed because data would not be statistically relevant.

Results Point of Contact

• Title: Beth Scanlan
• Organization: University of Arkansas for Medical Sciences

bscanlan@uams.edu

501-686-8274

Study Officials

• Loverd Peacock, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

• Yihong Kaufmann, PhD

  University of Arkansas

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 16, 2013
• Study Start: June 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 29, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-05

Locations

US (1)