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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754767
• Other study ID #: CDR0000614311
• Secondary ID: PNCC-03312-05-CU
• Status: Completed
• Phase: N/A
• First received: September 17, 2008
• Last updated: December 15, 2015
• Start date: June 2006
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapeutic Agent Toxicity
• Neurotoxicity
• Neurotoxicity Syndromes
• Peripheral Nervous System Diseases

Intervention

Drug:
• L-carnitine L-tartrate
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota
United States	Park Nicollet Cancer Center	St. Louis Park	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork		baseline, days 1 and 2 post chemo x 4 cycles	No
Primary	Sensitivity to light touch		baseline, days 1 and 2 post chemo x 4 cycles	No
Primary	Motor and sensory neuropathy as assessed by NCI CTCAE v3.0		baseline, days 1 and 2 post chemo x 4 cycles	No
Primary	Toxicity as assessed by NCI CTCAE v3.0		baseline, days 1 and 2 post chemo x 4 cycles	Yes
Primary	Tumor response		end of cancer treatment	No
Primary	Time to tumor progression		to end of cancer treatement	No
Primary	Survival		to end of course of cancer treatment	No