Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02012608
• Other study ID #: 202253
• Status: Terminated
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: April 2019

Study information

• Verified date: May 2019
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Glutamine
Oral glutamine for subjects undergoing breast conserving therapy
• Placebo
For subjects undergoing breast conserving therapy

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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