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Title:
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Randomized Placebo-controlled Trial of Acetyl-L-Carnitine (ALC) For the Prevention of Taxane Induced Neuropathy, Phase III - IRB # 09-095B
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Treatments:
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Acetyl L-Carnitine
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Disease Site:
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Cancer control
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Disease SubSite:
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Breast
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Drug Provided:
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Acetyl L-Carnitine
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Comments:
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Eligibility:
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Histologically confirmed primary invasive adenocarcinoma of the breast, Stage I-IIIA disease, No metastatic disease, Must have undergone modified radical mastectomy or breast-sparing surgery and radiotherapy, Planning to receive one of the following standard taxane-based systemic chemotherapy regimens as adjuvant therapy for breast cancer: Paclitaxel 80 mg/m² weekly for 12 weeks, Paclitaxel 175 mg/m² every other week for 4 courses (8 weeks), Paclitaxel 175 mg/m² every other week for 6 courses (12 weeks) , Docetaxel 75 mg/m² every 3 weeks for 4 courses (12 weeks), Docetaxel 75 mg/m² every 3 weeks for 6 courses (18 weeks), No history of neuropathy, Hormone receptor status not specified, Prior/Concurrent Therapy: See Disease Characteristics, Prior neoadjuvant chemotherapy allowed, No prior taxane therapy or biologic therapy, Concurrent biologic therapy allowed, No concurrent vitamin E, glutamine, gabapentin, nortriptyline, amitriptyline, or duloxetine hydrochloride, No concurrent anti-seizure medications, Concurrent hormonal therapy allowed, Concurrent participation in another therapeutic clinical trial allowed.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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