- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04749381
The Role of TCM on ERAS of Rectal Cancer Patients (RCT)
February 10, 2021 updated by: Aiwen Wu, Peking University Cancer Hospital & Institute
The Role of Traditional Chinese Medicine on Enhanced Recovery After Surgery for Patients With Rectal Cancer Undergoing Curative Surgery: A Randomized Controlled Trial
This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The hypothesis is that TCM can decrease the postoperative complications for rectal cancer.
So the study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.
Patients enrolled in this study will be randomized into two groups with TCM intervention or placebo.
The intervention will be described below.
Primary endpoint is postoperative complications.
Study Type
Interventional
Enrollment (Anticipated)
264
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
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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 to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written consent form;
- Age from 18 to 75 years old;
- Pathological diagnosis as rectal adenocarcinoma;
- undergo laparoscopic curative surgery;
- Patients' TCM syndrome accords with thoses of spleen deficiency syndrome;
Exclusion Criteria:
- Patients undergo non-curative surgeries;
- Participants with skin allergy, skin ulceration and diabetes mellitus with poor glycemic control;
- Participants with severe dysfunction of heart, liver and kidney, who could not receive TCM treatment;
- Women who are pregnant or breastfeeding;
- Participants have mental illness or have difficulty in language communication and are unable to complete the study;
- Participants could not cooperate with this researcher for other reasons.
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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TCM group
Rectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine.
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The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.
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PLACEBO_COMPARATOR: Control group
Rectal cancer patients randomized to this group will have acupoint application with placebo .
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The placebo acupoint application was made of black beans and honey, which shares the similar shape and smell of the experiment group, applied at the same acupoints.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: from operation to 30 days after operation
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Rates of the complications after curative surgery
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from operation to 30 days after operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recovery of urinary function
Time Frame: from removal of urinary catheter to 30 days after operation
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The rates of urinary retention after removal of urinary catheter
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from removal of urinary catheter to 30 days after operation
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Recovery of fart and bowel function
Time Frame: 7 days after operation
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The time of the first tart and first defecation after operation in days
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7 days after operation
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The European Organization of Quality of Life Questionnaire-colorectal-29
Time Frame: 30 days after operation
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Cancer Quality of Life Questionnaire-Colorectal-29, with scale from 1 to 4 for each items as QOL becomes poorer.
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30 days after operation
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Changes of TCM symptoms
Time Frame: 30 days after operation
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Changes of traditional Chinese medicine symptoms: all symptoms were recorded by 10 simple questions and then will be categorized in 4 different groups.
The aim of study tries to show the relationship with TCM application with the symptoms.
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30 days after operation
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Length of hospital stay
Time Frame: 30 days after operation
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Time of hospital stay in days
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30 days after operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiaoqiang Jia, M.D.;Ph.D, Xiyuan Hospital of China Academy of Chinese Medical Sciences
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 (ACTUAL)
September 28, 2020
Primary Completion (ANTICIPATED)
December 30, 2022
Study Completion (ANTICIPATED)
February 20, 2023
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
February 10, 2021
First Posted (ACTUAL)
February 11, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 11, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKUCH-R06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Rectal Cancer
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Ohio State University Comprehensive Cancer CenterNovartis Pharmaceuticals; National Comprehensive Cancer NetworkCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Recurrent Rectal CancerUnited States
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M.D. Anderson Cancer CenterRecruitingEvaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Rectal Cancer AJCC v8 | Stage IVC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage... and other conditionsUnited States
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OHSU Knight Cancer InstituteNatera, Inc.RecruitingEstablishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal CancerStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8United States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Rectal AdenocarcinomaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Taiho Pharmaceutical Co., Ltd.RecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8United States
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Jonsson Comprehensive Cancer CenterNatera, Inc.; The Joseph Drown FoundationRecruitingStage III Rectal Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC v8 | Stage IIIC Rectal Cancer AJCC v8 | Rectal Adenocarcinoma | Stage IIA Rectal Cancer AJCC v8 | Stage IIB Rectal Cancer AJCC v8 | Stage II Rectal Cancer AJCC v8 | Stage IIC Rectal Cancer AJCC v8 | Locally...United States
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Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
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City of Hope Medical CenterWithdrawnRecurrent Rectal Cancer | Stage I Rectal Cancer | Stage II Rectal Cancer | Stage III Rectal Cancer
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