Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial
Background: The high incidence and mortality rates of colorectal cancer (CRC) are a severe challenge in China. In patients with stage III and high-risk stage II CRC after radical resection and postoperative adjuvant chemoradiotherapy, 40–60% experience recurrence and metastasis. Several years of cli...
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Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.944475/full |
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| author | Liusheng Li Qian Qu Ning Cui Linlin Cai Jianhua Zou Jiao Wu Tengteng Hao Yu Wu |
| author_facet | Liusheng Li Qian Qu Ning Cui Linlin Cai Jianhua Zou Jiao Wu Tengteng Hao Yu Wu |
| author_sort | Liusheng Li |
| collection | DOAJ |
| description | Background: The high incidence and mortality rates of colorectal cancer (CRC) are a severe challenge in China. In patients with stage III and high-risk stage II CRC after radical resection and postoperative adjuvant chemoradiotherapy, 40–60% experience recurrence and metastasis. Several years of clinical practice have shown that traditional Chinese medicine, including Jianpi Huatan granule (JHG), effectively prevents stage III and high-risk stage II CRC recurrence and metastasis after radical resection and postoperative standard adjuvant chemotherapy. However, high-level systematic plans and evidence-based medicine are lacking in this regard. Therefore, this randomised control trial aimes to determine the efficacy of JHG in reducing stage III and high-risk stage II CRC metastasis and recurrence after radical resection and postoperative standard adjuvant chemotherapy.Methods: This is a multicentre, randomised, double-blind, placebo-controlled clinical trial. Three hundred and fifty patients with stage III or high-risk stage II CRC who completed adjuvant chemotherapy after radical resection will be recruited from eight medical centres in China and randomly assigned to test (n = 175) and control (n = 175) groups at a ratio of 1:1. The test group will receive oral JHG for 3 months, whereas the control group will receive oral placebo for 3 months. The primary outcomes will be the disease-free survival and 1-, 2-, and 3-years metastasis and recurrence rates, whereas the secondary outcomes will be quality of life and circulating tumour cells. The patients will be followed-up monthly during treatment and every 3–6 months thereafter until recurrence, metastasis, death, or the end of the study.Trial registration: This trial was registered at ClinicalTrials.gov (NCT03716063). |
| first_indexed | 2024-04-12T21:54:56Z |
| format | Article |
| id | doaj.art-4f0f100d9185491687c4acc6d7257179 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-12T21:54:56Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-4f0f100d9185491687c4acc6d72571792022-12-22T03:15:21ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-09-011310.3389/fphar.2022.944475944475Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trialLiusheng Li0Qian Qu1Ning Cui2Linlin Cai3Jianhua Zou4Jiao Wu5Tengteng Hao6Yu Wu7Department of Oncology, Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing, ChinaCollege of Integrated Traditional Chinese and Western Medicine, Binzhou Medical University, Binzhou, ChinaDepartment of Oncology, Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing, ChinaDepartment of Oncology, Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing, ChinaDepartment of Oncology, Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing, ChinaDepartment of Oncology, Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing, ChinaDepartment of Oncology, Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing, ChinaDepartment of Oncology, Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing, ChinaBackground: The high incidence and mortality rates of colorectal cancer (CRC) are a severe challenge in China. In patients with stage III and high-risk stage II CRC after radical resection and postoperative adjuvant chemoradiotherapy, 40–60% experience recurrence and metastasis. Several years of clinical practice have shown that traditional Chinese medicine, including Jianpi Huatan granule (JHG), effectively prevents stage III and high-risk stage II CRC recurrence and metastasis after radical resection and postoperative standard adjuvant chemotherapy. However, high-level systematic plans and evidence-based medicine are lacking in this regard. Therefore, this randomised control trial aimes to determine the efficacy of JHG in reducing stage III and high-risk stage II CRC metastasis and recurrence after radical resection and postoperative standard adjuvant chemotherapy.Methods: This is a multicentre, randomised, double-blind, placebo-controlled clinical trial. Three hundred and fifty patients with stage III or high-risk stage II CRC who completed adjuvant chemotherapy after radical resection will be recruited from eight medical centres in China and randomly assigned to test (n = 175) and control (n = 175) groups at a ratio of 1:1. The test group will receive oral JHG for 3 months, whereas the control group will receive oral placebo for 3 months. The primary outcomes will be the disease-free survival and 1-, 2-, and 3-years metastasis and recurrence rates, whereas the secondary outcomes will be quality of life and circulating tumour cells. The patients will be followed-up monthly during treatment and every 3–6 months thereafter until recurrence, metastasis, death, or the end of the study.Trial registration: This trial was registered at ClinicalTrials.gov (NCT03716063).https://www.frontiersin.org/articles/10.3389/fphar.2022.944475/fulljianpi huatan granulemetastasis and recurrencetraditional Chinese medicinerandomized controlled trialprotocolstage III and high-risk stage II colorectal cancer |
| spellingShingle | Liusheng Li Qian Qu Ning Cui Linlin Cai Jianhua Zou Jiao Wu Tengteng Hao Yu Wu Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial Frontiers in Pharmacology jianpi huatan granule metastasis and recurrence traditional Chinese medicine randomized controlled trial protocol stage III and high-risk stage II colorectal cancer |
| title | Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial |
| title_full | Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial |
| title_fullStr | Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial |
| title_full_unstemmed | Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial |
| title_short | Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial |
| title_sort | efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy study protocol for a randomised double blind placebo controlled multicentre trial |
| topic | jianpi huatan granule metastasis and recurrence traditional Chinese medicine randomized controlled trial protocol stage III and high-risk stage II colorectal cancer |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.944475/full |
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