L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast cancer.

Detailed Description
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OBJECTIVES: To evaluate the tolerability and usefulness of the dietary supplement, L-carnitine L-tartrate, in the prevention of chemotherapy-induced peripheral neuropathy in women with metastatic breast cancer. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. Arm II: Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. Patients complete questionnaires periodically to assess neuropathy, pain, fatigue, sleep, and activities of daily living. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Official Title
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Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer

Conditions
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Breast Cancer, Chemotherapeutic Agent Toxicity, Neurotoxicity

Intervention / Treatment
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* Drug: L-carnitine L-tartrate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of breast cancer Metastatic disease Scheduled to receive ≥ 1 of the following chemotherapy drugs: Paclitaxel Docetaxel Capecitabine Gemcitabine hydrochloride Concurrent enrollment in the University of Minnesota study Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors (Human Subjects Code 0508M72989) required Albumin-bound paclitaxel (Abraxane) Doxorubicin hydrochloride PATIENT CHARACTERISTICS: Life expectancy ≥ 6 months Serum creatinine < 2.0 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No history of seizures No uncontrolled hypertension No history of stroke No malabsorption syndrome No cognitive impairment No history of psychiatric disability affecting informed consent or compliance with drug intake Able to take oral medication Able to complete questionnaire(s) alone or with assistance PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent warfarin No concurrent radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. | Drug: L-carnitine L-tartrate<br>* Given orally<br>|
| Placebo Comparator: Arm II<br>Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork | Data was not analyzed due to study termination | baseline, days 1 and 2 post chemo x 4 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurotoxicity, chemotherapeutic agent toxicity, stage IV breast cancer, recurrent breast cancer