Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy

NCT00195013 | Completed Phase 3 Results

• 1 other identifier: 0309006308
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.

Conditions

Peripheral Neuropathy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Peripheral Neuropathy Score

  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.

  Duration of study, approximately 10 weeks per subject

Study Arms (2)

Glutamine

EXPERIMENTAL

10 grams three times a day (orally) for four days and then stop

Drug: glutamine

Placebo

PLACEBO COMPARATOR

10 grams three times a day (orally) for four days and then stop

Drug: Placebo

Interventions

glutamine DRUG

10 grams three times a day (orally) for four days and then stop

Also known as: NutreStore

Glutamine

Placebo DRUG

10 grams three times a day (orally) for four days and then stop

Also known as: sugar pill

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed breast cancer, Stage I, II, III or IV or other solid tumors.
• Patients must be receiving weekly paclitaxel or nab-paclitaxel chemotherapy or have recently completed paclitaxel or nab-paclitaxel chemotherapy and have at least a Grade I peripheral neuropathy (see Appendix A) because of therapy.
• Because no dosing or adverse event data are currently available on the use of glutamine in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
• ECOG performance status \<1 (Karnofsky \>90%).
• Life expectancy of greater than 3 months.
• Patients must have sufficient organ and marrow function so that paclitaxel treatment can be administered.
• The effects of glutamine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients who have experienced prior neuropathies not associated with chemotherapy
• Patients may not be receiving any other investigational agents.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• There are no known allergies associated with glutamine.
• Uncontrolled intercurrent illness that render the patient ineligible to receive paclitaxel chemotherapy.
• Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with glutamine. Breastfeeding should also be discontinued if the mother is treated with glutamine.
• Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with glutamine. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
• Concurrent chemotherapy with another drug known to cause neuropathy (CDDP or CBDCA or oxaliplatin) are excluded.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Breast Neoplasms

Interventions

Glutamine; Sugars

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; 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; Carbohydrates

Results Point of Contact

• Title: Linda Vahdat, MD
• Organization: Weill Cornell Medicine

ltv2001@med.cornell.edu

646-962-9888

Study Officials

• Linda Vahdat, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 19, 2005
• Study Start: December 1, 2003
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 6, 2018
• Results First Posted: August 18, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)