Status:
UNKNOWN
Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial
Lead Sponsor:
Nanjing NingQi Medicine Science and Technology Co., Ltd.
Collaborating Sponsors:
Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
This study is a randomized, placebo-controlled, double-blind, and multicenter clinical trial. Three hundred sixty postoperative patients with colon cancer stage IIa-IIIc will be randomly assigned into...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04690283
Start Date
January 1 2021
End Date
October 1 2022
Last Update
December 30 2020
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