Nervous System Diseases

All Conditions

Peripheral Nervous System Diseases

Neuromuscular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Oxaliplatin

Ginger

Licorice

Astragalus

Angelica

Dong Quai

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.

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.

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.

The intervention relates to a multiple granules, which contains 2.5% concentrated Huangqi-Guizhi-Wuwu decoction (a classical traditional Chinese prescription consists of astragalus membranaceus, cassia twig, radix paeoniae alba, ginger and jujube), 2.5% concentrated Danggui-Sini decoction (a classical traditional Chinese prescription consists of angelica sinensis, cassia twig, radix paeoniae alba, asarum, tetrapanax papyriferus, jujube and honey-fried licorice root), bitter principle, food colouring and starch.

Mimetic granules of Yiqi-Wenjing prescriptions

The intervention relates to a traditional Chinese prescription granules, which contains astragalus membranaceus, cassia twig, radix paeoniae alba, ginger and jujube.

Huangqi-Guizhi-Wuwu granules

The intervention relates to a traditional Chinese prescription granules, which contains angelica sinensis, cassia twig, radix paeoniae alba, asarum, tetrapanax papyriferus, jujube and honey-fried licorice root.

Danggui-Sini granules

Jiege Huo, Doctor

Guoli Wei, Doctor

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

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.

Subject diagnosed with colorectal cancer stages IIa-IIIc, 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, with Karnofsky performance status scale (Schag et al.1984) index ≥60 points and an expected survival time ≥6 months, over 18 years of age, men or women, without severe damage of the heart, liver, kidney or hematopoietic system.

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

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase Ⅲ Clinical Trial of Yiqi Wenjing Prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy

Individual participant data for reference include the vague name, gender, age, diagnosis, the type and number of chemotherapy regimens, the degree and grades of oxaliplatin-induced peripheral neuropathy

The degree of oxaliplatin-induced peripheral neuropathy will be evaluated according to the score of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty item scale(EORTC QLQ-CIPN20, 20-80 scores, higher scores mean a worse outcome), which is graded by the subject. In order to observe the dynamic change of OIPN, this trial sets multiple measure time points.

The grades of oxaliplatin-induced peripheral neuropathy will be evaluated according to the grades of National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE 5.0, 0-5 grades, higher grade means a worse outcome), which is graded by the doctor. In order to observe the dynamic change of OIPN, this trial sets multiple measure time points.

Quality of life will be evaluated according to the score of European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30, 28-112 scores, higher scores mean a worse outcome). In order to observe the dynamic change of QOL, this trial sets multiple measure time points.

The number of completed chemotherapy cycles will be recorded. If the result is less then 6, the specific reason should be noted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial	NCT04690283	Chemotherapy-in... Colorectal Canc...	Mimetic granule... Huangqi-Guizhi-... Danggui-Sini gr...	18 Years -	Nanjing NingQi Medicine Science and Technology Co., Ltd.
Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial	NCT04690283	Chemotherapy-in... Colorectal Canc...	Mimetic granule... Huangqi-Guizhi-... Danggui-Sini gr...	18 Years -	Nanjing NingQi Medicine Science and Technology Co., Ltd.

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