Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

Glutamine for the Prevention of Radiation Toxicity in Subjects Undergoing Breast Conserving Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Glutamine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glutamine; 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; Oral glutamine for subjects undergoing breast conserving therapy; Other Names: Gln; Q
Placebo Comparator: Placebo; Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day	Drug: Placebo; For subjects undergoing breast conserving therapy; Other Names: Dextrose; Dextrose monohydrate; Sugar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Loverd Peacock, MD, University of Arkansas; Study Chair: Yihong Kaufmann, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: breast
• Other Study ID Numbers: 202253