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

• Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ] [ Designated as safety issue: No ]
• Sensitivity to light touch [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ] [ Designated as safety issue: No ]
• Motor and sensory neuropathy as assessed by NCI CTCAE v3.0 [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ] [ Designated as safety issue: No ]
• Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: baseline, days 1 and 2 post chemo x 4 cycles ] [ Designated as safety issue: Yes ]
• Tumor response [ Time Frame: end of cancer treatment ] [ Designated as safety issue: No ]
• Time to tumor progression [ Time Frame: to end of cancer treatement ] [ Designated as safety issue: No ]
• Survival [ Time Frame: to end of course of cancer treatment ] [ Designated as safety issue: No ]

• Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork [ Designated as safety issue: No ]
• Sensitivity to light touch [ Designated as safety issue: No ]
• Motor and sensory neuropathy as assessed by NCI CTCAE v3.0 [ Designated as safety issue: No ]
• Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
• Tumor response [ Designated as safety issue: No ]
• Time to tumor progression [ Designated as safety issue: No ]
• Survival [ Designated as safety issue: No ]

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.

• Breast Cancer
• Chemotherapeutic Agent Toxicity
• Neurotoxicity

• Dietary Supplement: L-carnitine L-tartrate
  Given orally
• Other: placebo
  Given orally

• Experimental: 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.
  Intervention: Dietary Supplement: L-carnitine L-tartrate
• Placebo Comparator: 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.
  Intervention: Other: placebo

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