Trial Outcomes & Findings for Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy (NCT NCT00195013)

NCT ID: NCT00195013

Last Updated: 2018-06-06

Results Overview

Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result). Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 30 participants
• Primary outcome timeframe: Duration of study, approximately 10 weeks per subject
• Results posted on: 2018-06-06

Participant Flow

Participant milestones

Measure	Glutamine 10 grams three times a day (orally) for four days and then stop glutamine: 10 grams three times a day (orally) for four days and then stop	Placebo 10 grams three times a day (orally) for four days and then stop Placebo: 10 grams three times a day (orally) for four days and then stop
Overall Study STARTED	14	16
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Glutamine n=14 Participants 10 grams three times a day (orally) for four days and then stop glutamine: 10 grams three times a day (orally) for four days and then stop	Placebo n=16 Participants 10 grams three times a day (orally) for four days and then stop Placebo: 10 grams three times a day (orally) for four days and then stop	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=16 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=14 Participants	14 Participants n=16 Participants	25 Participants n=30 Participants
Age, Categorical >=65 years	3 Participants n=14 Participants	2 Participants n=16 Participants	5 Participants n=30 Participants
Age, Continuous	58 years n=14 Participants	55 years n=16 Participants	58 years n=30 Participants
Sex: Female, Male Female	14 Participants n=14 Participants	16 Participants n=16 Participants	30 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=14 Participants	0 Participants n=16 Participants	0 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 participants n=14 Participants	16 participants n=16 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: Duration of study, approximately 10 weeks per subject

Used the clinical total neuropathy score scale (TNSc). The presence of sensory, motor, pin sensibility, vibration sensibility, DTR, autonomic symptoms was assessed. For each item, the possible score ranged between 0 (normal) and 4 (worst possible result).

Outcomes calculated as neuropathy score value at 10 Weeks minus neuropathy score value at Baseline. Increased score value indicates increased neuropathy severity.

Outcome measures

Measure	Glutamine n=14 Participants 10 grams three times a day (orally) for four days and then stop glutamine: 10 grams three times a day (orally) for four days and then stop	Placebo n=16 Participants 10 grams three times a day (orally) for four days and then stop Placebo: 10 grams three times a day (orally) for four days and then stop
Change in Peripheral Neuropathy Score	0.3 Change in Total Neuropathy Score Interval -5.0 to 3.0	0.9 Change in Total Neuropathy Score Interval -6.0 to 7.0

Adverse Events

Glutamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Linda Vahdat, MD

Weill Cornell Medicine

Phone: 646-962-9888

Email: ltv2001@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place