Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy
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ClinicalTrials.gov Identifier: NCT00195013 |
Recruitment Status
:
Completed
First Posted
: September 19, 2005
Results First Posted
: August 18, 2017
Last Update Posted
: August 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Neuropathy Breast Cancer | Drug: glutamine Drug: Placebo | Phase 3 |
- Determine whether oral glutamine supplementation can reduce the symptoms and signs of peripheral neuropathy.
- Determine whether alterations in the symptoms and signs of peripheral neuropathy are correlated with an alteration of circulating nerve growth factor or insulin-like growth factor levels.
- Assess whether oral glutamine affects circulating nerve growth factor or insulin-like growth factor levels.
- Assess whether glutamine interferes with paclitaxel pharmacokinetics
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Placebo-controlled Trial of Glutamine to Reduce the Signs and Symptoms of Peripheral Neuropathy in Breast Cancer Patients With a Mild Peripheral Neuropathy Receiving Paclitaxel Chemotherapy |
Study Start Date : | December 2003 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Glutamine
10 grams three times a day (orally) for four days and then stop
|
Drug: glutamine
10 grams three times a day (orally) for four days and then stop
Other Name: NutreStore
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Placebo Comparator: Placebo
10 grams three times a day (orally) for four days and then stop
|
Drug: Placebo
10 grams three times a day (orally) for four days and then stop
Other Name: sugar pill
|
- Change in Peripheral Neuropathy Score [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195013
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10021 |
Principal Investigator: | Linda Vahdat, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00195013 History of Changes |
Other Study ID Numbers: |
0309006308 |
First Posted: | September 19, 2005 Key Record Dates |
Results First Posted: | August 18, 2017 |
Last Update Posted: | August 18, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Additional relevant MeSH terms:
Breast Neoplasms Peripheral Nervous System Diseases Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neuromuscular Diseases Nervous System Diseases |