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

Phase 4

Terminated

• Conditions: Neurotoxicity; Chemotherapeutic Agent Toxicity; Breast Cancer
• Interventions: Other: placebo; Drug: L-carnitine L-tartrate

• Registration Number: NCT00754767
• Lead Sponsor: HealthPartners Institute

Brief 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.

Study Timeline

• Study Start: 2007-01-02
• Primary Completion: 2008-04-02
• Study Completion: 2008-05-02
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Status Verified: 2015-10
• Results First Submitted: 2017-03-01
• Results First Submitted QC: 2017-03-01
• Results First Posted: 2017-04-13
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm II	placebo	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.
Arm I	L-carnitine L-tartrate	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.

Primary Outcome Measures

Name	Time	Method
Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork	baseline, days 1 and 2 post chemo x 4 cycles	Data was not analyzed due to study termination

Trial Locations

Locations (2)

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Park Nicollet Cancer Center; 🇺🇸 Saint Louis Park, Minnesota, United States