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

Sponsored by:	Park Nicollet Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00754767

Purpose

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.

Condition	Intervention
Breast Cancer Cancer-Related Problem/Condition	Drug: L-carnitine L-tartrate Drug: placebo

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Peripheral Nerve Disorders

Drug Information available for: Carnitine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	Pilot Study of L-Carnitine Supplementation in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Women With Metastatic Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Vibratory threshold as assessed by the Rydel-Seiffer Quantitative Tuning Fork [ Designated as safety issue: No ]
Sensitivity to light touch [ Designated as safety issue: No ]
Motor and sensory neuropathy as assessed by NCI CTCAE v3.0 [ Designated as safety issue: No ]
Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Tumor response [ Designated as safety issue: No ]
Time to tumor progression [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	June 2006
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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.	Drug: L-carnitine L-tartrate Given orally
Arm II: Placebo Comparator 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.	Drug: placebo Given orally

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754767

Locations

United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Park Nicollet Cancer Center
St. Louis Park, Minnesota, United States, 55426

Sponsors and Collaborators

Park Nicollet Cancer Center

Investigators

Principal Investigator:

Alice Shapiro, PhD

Park Nicollet Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Park Nicollet Cancer Center ( Alice Shapiro )
Study ID Numbers:	CDR0000614311, PNCC-03312-05-C, UMN-0508M72428
Study First Received:	September 17, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00754767
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

neurotoxicity
chemotherapeutic agent toxicity
stage IV breast cancer
recurrent breast cancer

Study placed in the following topic categories:

Neuromuscular Diseases
Skin Diseases
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neurotoxicity syndromes

Breast Neoplasms
Carnitine
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Vitamin B Complex
Neoplasms by Site
Growth Substances
Vitamins

Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009