- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690283
Yiqi Wenjing Prescriptions Preventive Efficacy of Oxaliplatin-induced Peripheral Neuropathy Clinical Trial (YWPPEOPNCT)
December 26, 2020 updated by: Nanjing NingQi Medicine Science and Technology Co., Ltd.
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase Ⅲ Clinical Trial of Yiqi Wenjing Prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy
This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial of Yiqi Wenjing prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy.
Study Overview
Status
Unknown
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.
Study Type
Interventional
Enrollment (Anticipated)
360
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiege Huo, Doctor
- Phone Number: +86-153-120-19156
- Email: hjg16688@126.com
Study Contact Backup
- Name: Guoli Wei, Doctor
- Phone Number: +86-173-270-06155
- Email: weiguoli1987@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo-control group
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.
|
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.
Other Names:
|
Experimental: Treatment group I
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.
|
The intervention relates to a traditional Chinese prescription granules, which contains astragalus membranaceus, cassia twig, radix paeoniae alba, ginger and jujube.
|
Experimental: Treatment group II
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 traditional Chinese prescription granules, which contains angelica sinensis, cassia twig, radix paeoniae alba, asarum, tetrapanax papyriferus, jujube and honey-fried licorice root.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The dynamic change of the degree of oxaliplatin-induced peripheral neuropathy
Time Frame: 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.
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The dynamic change of the grades of oxaliplatin-induced peripheral neuropathy
Time Frame: 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.
|
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.
|
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.
|
The dynamic change of quality of life
Time Frame: 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.
|
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.
|
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.
|
The number of completed chemotherapy cycles
Time Frame: 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).
|
The number of completed chemotherapy cycles will be recorded.
If the result is less then 6, the specific reason should be noted.
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2021
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
December 13, 2020
First Submitted That Met QC Criteria
December 26, 2020
First Posted (Actual)
December 30, 2020
Study Record Updates
Last Update Posted (Actual)
December 30, 2020
Last Update Submitted That Met QC Criteria
December 26, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBE2019750381
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
IPD Sharing Time Frame
Starting in January 2025 and forever
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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