Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial of Yiqi Wenjing prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing NingQi Medicine Science and Technology Co., Ltd.
• Collaborators: Fudan University; Jiangsu Cancer Institute & Hospital; Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital with Nanjing Medical University

Criteria

Inclusion Criteria:

• Subject diagnosed with colorectal cancer stages IIa-IIIc, confirmed by histopathological examination, according to CSCO guidelines for diagnosis and treatment of colorectal cancer.

• Subject suitable for receiving FOLFOX4 or mFOLFOX6 as adjuvant chemotherapy after radical resection of colorectal cancer, receiving each dose and cumulative dose of oxaliplatin are 85mg/m2 and ≥540 mg/m2 respectively.

• Subject with Karnofsky performance status scale (Schag et al.1984) index ≥60 points and an expected survival time ≥6 months.

• Subject over 18 years of age, men or women.

• Subject without severe damage of the heart, liver, kidney or hematopoietic system.

Exclusion Criteria:

• Subject with any grade of peripheral neuropathy.

• Subject who has ever received treatment of neurotoxic chemotherapeutics, such as oxaliplatin, cisplatin, taxanes, or vinca alkaloids.

• Subject who is receiving agents with potential preventive or therapeutic effects to neuropathy, such as duloxedine, carbamazepine, venlafaxine, gabapentin, pregabalin, phenytoin, valproate, milnacipran, or tricyclic antidepressant.

• Subject who is participating or have participated in other clinical trials.

• Subject with a family history of hereditary/familial neuropathy.

• Subject who cannot take drugs orally.

• Subject with mental illness who cannot cooperate.

• Pregnant or lactation period women.