Evidence map›Paper›PMID 37461034›Full record

ArticleBMC complementary medicine and therapies2023

Efficacy and safety of Xian-Lian-Jie-Du optimization decoction as an adjuvant treatment for prevention of recurrence in patients with stage IIIB/IIIC colon cancer: study protocol for a multicentre, randomized controlled trial.

Xuechen Geng, Ziqiang Wang, Li Feng, Yanhong Gu, Renjie Wang, Qinghua Yao, Yangxian Xu, Jianyu Wu, Zhiwei Jiang, Kai Chen and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05709249 (Efficacy of Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer:a Study Protocol for a Randomized Controlled Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05709249 phase3recruitingnot on this map

Efficacy of Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer:a Study Protocol for a Randomized Controlled Trial

TypeinterventionalSponsorJiangsu Famous Medical Technology Co., Ltd.Ran2022 to 2028Enrolled730ConditionsColon CancerArmsXLJDOD compound granule, placebo (XLJDOD mimetic agent)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 12 institutions in 1 country.

Xuechen GengThe First Clinical Medical College, Jiangsu Collaborative Innovation Center of Traditional Chinese Medicine Prevention and Treatment of Tumor, Nanjing University of Chinese Medicine, Nanjing, China.
Ziqiang WangDepartment of General Surgery, Colorectal Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Li FengTraditional Chinese Medicine Department, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
Yanhong GuDepartment of Oncology and Cancer Rehabilitation Centre, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Renjie WangDepartment of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.
Qinghua YaoDepartment of Integrated Chinese and Western Medicine, Institute of Basic Medicine and Cancer (IBMC), The Cancer HospitalUniversity of Chinese Academy of Sciences (Zhejiang Cancer Hospital)Chinese Academy of Sciences, Hangzhou, China.
Yangxian XuDepartment of General Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Jianyu WuNo. 2 Surgery Department, The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangdong, China.
Zhiwei JiangDepartment of General Surgery, The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
Kai ChenDepartment of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Wenwei HuDepartment of Oncology, The Third Affiliated Hospital of Soochow University, Changzhou, China.
Dongxin TangClinical Medical Research Center, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, China.
Jiege HuoAffiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Jiangsu Province Academy of Traditional Chinese Medicine, Nanjing, China.
Ling LiChinese Evidence-Based Medicine Center, NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Sichuan Center of Technology Innovation for Real World Data, West China Hospital, Sichuan University, Chengdu, China.
Qianqian BuThe First Clinical Medical College, Jiangsu Collaborative Innovation Center of Traditional Chinese Medicine Prevention and Treatment of Tumor, Nanjing University of Chinese Medicine, Nanjing, China.
Shuoqi ZhaoThe First Clinical Medical College, Jiangsu Collaborative Innovation Center of Traditional Chinese Medicine Prevention and Treatment of Tumor, Nanjing University of Chinese Medicine, Nanjing, China.
Bei ZhangState Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China. zhangbei@sysucc.org.cn.
Haibo ChengThe First Clinical Medical College, Jiangsu Collaborative Innovation Center of Traditional Chinese Medicine Prevention and Treatment of Tumor, Nanjing University of Chinese Medicine, Nanjing, China. haibocheng@njucm.edu.cn.
Nanjing University of Chinese Medicine · CNSichuan University · CNSoochow University · CNAffiliated Hospital of Guizhou Medical University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Affiliated Hospital of Guangzhou University of Chinese Medicine · CNFudan University Shanghai Cancer Center · CNJiangsu Province Hospital · CNNanjing Medical University · CNShanghai University of Traditional Chinese Medicine · CNSun Yat-sen University Cancer Center · CNZhejiang Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionColon cancer remains one of the most prevalent cancers worldwide. Unfortunately, there are no recognized and effective therapeutic strategies to prevent tumor recurrence after radical resection and chemotherapy, and the disease-free survival (DFS) in patients with stage IIIB or IIIC disease remains unsatisfactory. Xian-Lian-Jie-Du optimization decoction (XLJDOD) is a Chinese herbal medicine (CHM) empirical prescription, which has been validated experimentally and clinically that could inhibit the progression of colorectal cancer and ameliorate the symptoms. The purpose of this study is to evaluate the efficacy and safety of XLJDOD in prevention of recurrence of colon cancer.

methodsThis study is a multi-center, double-blind, randomized, placebo-controlled trial conducted at 13 hospitals of China. Following the completion of surgery and adjuvant 5- fluorouracil-based chemotherapy, a total of 730 subjects with stage IIIB or IIIC colon cancer will be randomized in a 1:1 ratio to an intervention group (n = 365; XLJDOD compound granule) and a control group (n = 365; Placebo). Patients will receive 6-month treatments and be followed up with 3 monthly assessments for 2 years. The primary outcome is 2-year DFS rate and the secondary outcomes are 1, 2-year relapse rate (RR), overall survival (OS) and quality of life (QoL). Safety outcomes such as adverse events will be also assessed. A small number of subgroup analysis will be carried out to explore the heterogeneity of effects of XLJDOD. DISCUSSION: The outcomes from this randomized controlled trial will provide objective evidences to evaluate XLJDOD's role as an adjuvant treatment in colon cancer.

trial registrationwww. CLINICALTRIALS: gov , identifier: NCT05709249. Registered on 31 Jan 2023.

Indexed as

Colonic NeoplasmsQuality of LifeDisease-Free SurvivalDouble-Blind MethodHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeChinese herbal medicineColon cancerProtocolRandomized controlled trialXian-Lian-Jie-Du optimization decoction

Identifiers

PMID37461034
PMCPMC10351122
OpenAlexW4384525545

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.