Clinical trial NCT04690283: Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase Ⅲ Clinical Trial of Yiqi Wenjing Prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chemotherapy-induced Peripheral Neuropathy
Colorectal Cancer
Keywords: clinical trial
Yiqi Wenjing prescriptions
oxaliplatin-induced peripheral neuropathy
randomized
placebo-controlled
Lead sponsor: Nanjing NingQi Medicine Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The First Affiliated Hospital with Nanjing Medical University
name: Jiangsu Cancer Institute & Hospital
name: Fudan University
First posted: 2020-12-30
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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 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.

Eligibility 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.

Primary outcomes:
measure: The dynamic change of the degree of oxaliplatin-induced peripheral neuropathy
timeFrame: On 1 day before and 3 days after the beginning of each cycle(each FOLFOX4 or mFOLFOX6 cycle is 14 days, each XELOX cycle is 21 days) up to Cycle 6, 1 month after the end of Cycle 6, and then every 3 months up to 1 year.
Secondary outcomes:
measure: The dynamic change of the grades of oxaliplatin-induced peripheral neuropathy
timeFrame: On 1 day before the beginning of each cycle(each FOLFOX4 or mFOLFOX6 cycle is 14 days, each XELOX cycle is 21 days) up to Cycle 6.
measure: The dynamic change of quality of life
timeFrame: On 1 day before the beginning of each cycle(each FOLFOX4 or mFOLFOX6 cycle is 14 days, each XELOX cycle is 21 days) up to Cycle 6.
measure: The number of completed chemotherapy cycles
timeFrame: At the end of Cycle 6 or after the last chemotherapy(each FOLFOX4 or mFOLFOX6 cycle is 14 days, each XELOX cycle is 21 days).
Other outcomes:
Locations:
Study officials:
References:
citation: Gu Z, Wei G, Zhu L, Zhu L, Hu J, Li Q, Cai G, Lu H, Liu M, Chen C, Ji Y, Li G, Huo J. Preventive Efficacy and Safety of Yiqi-Wenjing-Fang Granules on Oxaliplatin-Induced Peripheral Neuropathy: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Evid Based Complement Alternat Med. 2021 Sep 29;2021:5551568. doi: 10.1155/2021/5551568. eCollection 2021.