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

HealthPartners Institute

Status and phase: Terminated; Phase 4

Conditions: Chemotherapeutic Agent Toxicity; Breast Cancer; Neurotoxicity

Treatments: Drug: L-carnitine L-tartrate; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00754767

PNCC-03312-05-C

UMN-0508M72428

CDR0000614311

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

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.

Treatment:

Drug: L-carnitine L-tartrate

Arm II

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo