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

• Status: Terminated
• Trial end date: 2008-05-02
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthPartners Institute

Criteria

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