L-Carnitine L-Tartrate 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.

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