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

Phase 4TerminatedNCT00754767

HealthPartners Institute2 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer Chemotherapeutic Agent Toxicity Neurotoxicity

Interventions

L-carnitine L-tartrateDRUG

Given orally

placeboOTHER

Given orally

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (2)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Outcomes

Primary Outcomes

Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork

Data was not analyzed due to study termination

Time frame: baseline, days 1 and 2 post chemo x 4 cycles

Data from ClinicalTrials.gov

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