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Sponsored by: |
Park Nicollet Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00754767 |
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 |
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Breast Cancer Cancer-Related Problem/Condition |
Drug: L-carnitine L-tartrate Drug: placebo |
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 |
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 |
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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.
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Drug: L-carnitine L-tartrate
Given orally
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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.
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Drug: placebo
Given orally
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OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Scheduled to receive ≥ 1 of the following chemotherapy drugs:
Gemcitabine hydrochloride
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Principal Investigator: | Alice Shapiro, PhD | Park Nicollet Cancer Center |
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 |
neurotoxicity chemotherapeutic agent toxicity stage IV breast cancer recurrent breast cancer |
Neuromuscular Diseases Skin Diseases Neurotoxicity Syndromes Peripheral Nervous System Diseases Neurotoxicity syndromes |
Breast Neoplasms Carnitine Breast Diseases Recurrence |
Neoplasms Vitamin B Complex Neoplasms by Site Growth Substances Vitamins |
Physiological Effects of Drugs Nervous System Diseases Micronutrients Pharmacologic Actions |