Glutamine for the Prevention of Radiation Toxicity in Subjects Conserving Therapy

• Sponsor: University of Arkansas (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02012608
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 58
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Glutamine; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Glutamine for the Prevention of Radiation Toxicity in Subjects Undergoing Breast Conserving Therapy
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria [12 days and 30 days]

   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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

• University of Arkansas

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 8, 2017

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT02012608
• Other Study ID Numbers: 202253
• First Posted: Dec 16, 2013
• Last Update Posted: May 29, 2019
• Last Verified: May 1, 2019

• Keywords provided by University of Arkansas: breast

Study Results

Participant Flow

Arm/Group Title	Glutamine	Placebo
Arm/Group Description	Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day Glutamine: Oral glutamine for subjects undergoing breast conserving therapy	Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day Placebo: For subjects undergoing breast conserving therapy
Period Title: Overall Study
STARTED	7	7
COMPLETED	4	7
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Glutamine	Placebo	Total
Arm/Group Description	Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day Glutamine: Oral glutamine for subjects undergoing breast conserving therapy	Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day Placebo: For subjects undergoing breast conserving therapy	Total of all reporting groups
Overall Participants	7	7	14
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 71.4%	3 42.9%	8 57.1%
>=65 years	2 28.6%	4 57.1%	6 42.9%
Sex: Female, Male (Count of Participants)
Female	7 100%	7 100%	14 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 14.3%	1 14.3%	2 14.3%
White	6 85.7%	6 85.7%	12 85.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria
Description	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".
Time Frame	12 days and 30 days

Outcome Measure Data

Analysis Population Description

No data displayed because Outcome Measure has zero total participants analyzed and no data was collected.

Arm/Group Title	Glutamine	Placebo
Arm/Group Description	Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day Glutamine: Oral glutamine for subjects undergoing breast conserving therapy	Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day Placebo: For subjects undergoing breast conserving therapy
Measure Participants	0	0

Adverse Events

Time Frame	3 years
Arm/Group Title	Glutamine		Placebo
Arm/Group Description	Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day Glutamine: Oral glutamine for subjects undergoing breast conserving therapy		Powdered Dextrose, 8.33 grams by mouth TID for 30 days, so that daily dose is 25 grams per day Placebo: For subjects undergoing breast conserving therapy
All Cause Mortality
	Glutamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Glutamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Glutamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)		5/7 (71.4%)
Blood and lymphatic system disorders
anemia	2/7 (28.6%)	2	0/7 (0%)	0
hyperkalemia	0/7 (0%)	0	1/7 (14.3%)	1
decreased lymphocyte count	1/7 (14.3%)	1	0/7 (0%)	0
increased alkaline phosphatase	0/7 (0%)	0	1/7 (14.3%)	1
chloride out of range	0/7 (0%)	0	1/7 (14.3%)	1
Gastrointestinal disorders
nausea	1/7 (14.3%)	1	0/7 (0%)	0
General disorders
fatigue	2/7 (28.6%)	2	0/7 (0%)	0
Reproductive system and breast disorders
breast pain	0/7 (0%)	0	1/7 (14.3%)	1
asymptomatic breast edema	1/7 (14.3%)	1	0/7 (0%)	0
breast fibrosis/fat necrosis	1/7 (14.3%)	1	0/7 (0%)	0
Skin and subcutaneous tissue disorders
skin hyperpigmentation	2/7 (28.6%)	2	2/7 (28.6%)	2
skin erythema	3/7 (42.9%)	3	3/7 (42.9%)	3
telangiectasia	1/7 (14.3%)	1	0/7 (0%)	0

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.