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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00775645 |
RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it works compared with a placebo in preventing neuropathy in women with stage I, stage II, or stage IIIA breast cancer undergoing chemotherapy.
Condition | Intervention | Phase |
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Breast Cancer Cancer-Related Problem/Condition Fatigue |
Dietary Supplement: acetyl-L-carnitine hydrochloride Other: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III |
Estimated Enrollment: | 380 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks.
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Dietary Supplement: acetyl-L-carnitine hydrochloride
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo 3 times daily for 24 weeks.
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Other: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to planned adjuvant chemotherapy regimen for breast cancer (paclitaxel weekly for 12 weeks vs paclitaxel biweekly for 4 courses [8 weeks] vs paclitaxel biweekly for 6 courses [12 weeks] vs docetaxel every 3 weeks for 4 courses [12 weeks] vs docetaxel every 3 weeks for 6 courses [18 weeks]) and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.
Blood samples are collected at baseline and at week 12 for biomarker analysis (nerve growth factor levels) by ELISA, DNA extraction, and genotyping analysis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary invasive adenocarcinoma of the breast
Planning to receive one of the following standard taxane-based systemic chemotherapy regimens as adjuvant therapy for breast cancer:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000617081, SWOG-S0715 |
Study First Received: | October 17, 2008 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00775645 History of Changes |
Health Authority: | Unspecified |
neurotoxicity chemotherapeutic agent toxicity fatigue |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Nootropic Agents Fatigue Vitamin B Complex Neurotoxicity Syndromes Skin Diseases Breast Neoplasms Trace Elements |
Signs and Symptoms Vitamins Micronutrients Taxane Breast Diseases Carnitine Acetylcarnitine |
Nootropic Agents Vitamin B Complex Fatigue Skin Diseases Growth Substances Physiological Effects of Drugs Breast Neoplasms Pharmacologic Actions Signs and Symptoms |
Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Micronutrients Central Nervous System Agents Breast Diseases Carnitine Acetylcarnitine |