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

Nanjing NingQi Medicine Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Chemotherapy-induced Peripheral Neuropathy; Colorectal Cancer

Treatments: Drug: Mimetic granules of Yiqi-Wenjing prescriptions; Drug: Danggui-Sini granules; Drug: Huangqi-Guizhi-Wuwu granules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04690283

SBE2019750381

Details and patient eligibility

About

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

Full 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 treatment group I, treatment group II and placebo-control group, taking Huangqi Guizhi Wuwu granules, Danggui Sini granules and the mimetic granules of Yiqi Wenjing granules respectively. All subjects will receive mFOLFOX6 or FOLFOX4 or XELOX chemotherapy regimen along with traditional Chinese medicine(TCM) or placebo treatment per day for at least three months and one year follow up. EORTC QLQ-CIPN20 will be used to assess the degree of peripheral neuropathy as the primary outcome measure. Grades of OIPN evaluated by NCI-CTCAE 5.0, quality of life evaluated by EORTC QLQ-C30, chemotherapeutic efficacy evaluated by RESIST 1.1, and the number of completed chemotherapy cycles are selected as the secondary outcome measures.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 3 patient groups, including a placebo group

Placebo-control group

Placebo Comparator group

Description:

Subjects will receive FOLFOX4 or mFOLFOX6 or XELOX chemotherapy regimen and placebo treatment twice a day (1/2 bag, morning and evening) for at least three months and one year follow up.

Treatment:

Drug: Mimetic granules of Yiqi-Wenjing prescriptions

Treatment group I

Experimental group

Description:

Subjects will receive FOLFOX4 or mFOLFOX6 or XELOX chemotherapy regimen and orally take Huangqi Guizhi Wuwu granules twice a day (1/2 bag, morning and evening) for at least three months and one year follow up.

Treatment:

Drug: Huangqi-Guizhi-Wuwu granules

Treatment group II

Experimental group

Description:

Subjects will receive FOLFOX4 or mFOLFOX6 or XELOX chemotherapy regimen and orally take Danggui Sini granules twice a day (1/2 bag, morning and evening) for at least three months and one year follow up.

Treatment:

Drug: Danggui-Sini granules