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Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

ABSTRACT: Primary objective: To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer. Secondary objective: * To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale). * To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months * To assess the effects of xaliproden on the time to complete recovery from PSN * To evaluate the safety profile of xaliproden

DISEASE(S): Patient With Oxaliplatin-induced Peripheral Sensory Neuropathy After Having Completed An Oxaliplatin-containing Chemotherapy Regimen Post Complete Surgical Removal Of Primary Colorectal Tumor,Colorectal Neoplasms,Sensory Peripheral Neuropathy

PROVIDER: 2049763 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity

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