The Role of TCM on ERAS of Rectal Cancer Patients

Phase 2

• Conditions: Rectal Cancer
• Interventions: Combination Product: acupoint with TCM; Combination Product: acupoint with placebo

• Registration Number: NCT04749381
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.

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 Timeline

• Study Start: 2020-09-28
• Study First Submitted: 2020-10-09
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11
• Primary Completion: 2022-12-30
• Study Completion: 2023-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM group	acupoint with TCM	Rectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine.
Control group	acupoint with placebo	Rectal cancer patients randomized to this group will have acupoint application with placebo .

Primary Outcome Measures

Name	Time	Method
Postoperative complications	from operation to 30 days after operation	Rates of the complications after curative surgery

Secondary Outcome Measures

Name	Time	Method
recovery of urinary function	from removal of urinary catheter to 30 days after operation	The rates of urinary retention after removal of urinary catheter
Recovery of fart and bowel function	7 days after operation	The time of the first tart and first defecation after operation in days
The European Organization of Quality of Life Questionnaire-colorectal-29	30 days after operation	Cancer Quality of Life Questionnaire-Colorectal-29, with scale from 1 to 4 for each items as QOL becomes poorer.
Changes of TCM symptoms	30 days after operation	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.
Length of hospital stay	30 days after operation	Time of hospital stay in days

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China