NCT00754767

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

Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-induced Peripheral Neuropathy in Women With Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer
• Chemotherapeutic Agent Toxicity
• Neurotoxicity

Interventions

Type	Name	Description
DRUG	L-carnitine L-tartrate	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2007-01-02
• Primary completion: 2008-04-02
• Completion: 2008-05-02
• First posted: 2008-09-18
• Last updated: 2017-09-11
• Results posted: 2017-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study