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

NCT ID: NCT00754767

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-02
• Study Completion Date: 2008-05-02

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.

Conditions

Breast Cancer; Chemotherapeutic Agent Toxicity; Neurotoxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

L-carnitine L-tartrate

Intervention Type: DRUG

Given orally

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

Interventions

L-carnitine L-tartrate

Given orally

Intervention Type: DRUG

placebo

Given orally

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice Shapiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Park Nicollet Cancer Center

Locations

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Countries

United States

Other Identifiers

PNCC-03312-05-C

Identifier Type: -

Identifier Source: secondary_id

UMN-0508M72428

Identifier Type: -

Identifier Source: secondary_id

CDR0000614311

Identifier Type: -

Identifier Source: org_study_id