Abstract
We conducted a controlled double-blind randomized study in patients with advanced/recurrent colorectal cancer to investigate the efficacy of Goshajinkigan (GJG) for peripheral neurotoxicity induced by FOLFOX therapy. The primary endpoint is the incidence of peripheral neurotoxicity > or = Grade 2 after eight cycles of chemotherapy. The secondary endpoints are the incidence of peripheral neurotoxicity of each grade after each cycle, the psychometric properties of the FACT/GOG-Ntx, time to occurrence of neurotoxicity, time to treatment failure, progression-free survival, response rate and toxicity. Eighty patients are required in the study (40 patients per group).
Publication types
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Clinical Trial, Phase II
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adolescent
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Antimetabolites, Antineoplastic / pharmacology
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Antimetabolites, Antineoplastic / therapeutic use*
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Antineoplastic Combined Chemotherapy Protocols / adverse effects*
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use
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Child
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Colorectal Neoplasms / drug therapy
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Disease-Free Survival
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Dose-Response Relationship, Drug
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Double-Blind Method
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Drug Administration Schedule
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Drug Interactions
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Drugs, Chinese Herbal / pharmacology*
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Female
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Fluorouracil / pharmacology
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Fluorouracil / therapeutic use
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Humans
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Leucovorin / pharmacology
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Leucovorin / therapeutic use
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Male
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Neoplasm Staging
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Neurotoxicity Syndromes / drug therapy*
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Organoplatinum Compounds / pharmacology
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Organoplatinum Compounds / therapeutic use
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Oxaliplatin
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Placebos
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Young Adult
Substances
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Antimetabolites, Antineoplastic
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Drugs, Chinese Herbal
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Organoplatinum Compounds
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Placebos
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gosha-jinki-gan
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Oxaliplatin
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Leucovorin
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Fluorouracil