YWPPEOPNCT
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase Ⅲ Clinical Trial of Yiqi Wenjing Prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy
Sponsor study identifier
interventional
360
0 countries
N/A
Study Start
January 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial of Yiqi Wenjing prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 13, 2020
Actual (reported)December 30, 2020
Actual (reported)January 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The dynamic change of the degree 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.
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 dynamic change of the grades of oxaliplatin-induced peripheral neuropathy
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
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
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).
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.
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.
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.
First Submitted
December 13, 2020
First Posted
December 30, 2020
Study Start
January 1, 2021
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 astragalus membranaceus, cassia twig, radix paeoniae alba, ginger and jujube.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 30, 2020
Record last verified: 2020-12
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
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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