The Role of TCM on ERAS of Rectal Cancer Patients (RCT)

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: Rectal Cancer
• Intervention / Treatment: Combination product: acupoint with TCM; Combination product: acupoint with placebo

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

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

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.	Combination product: acupoint with TCM; The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.
PLACEBO_COMPARATOR: Control group; Rectal cancer patients randomized to this group will have acupoint application with placebo .	Combination product: acupoint with placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Rates of the complications after curative surgery	from operation to 30 days after operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Xiaoqiang Jia, M.D.;Ph.D, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

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

• Keywords: Quality of life; Compliance; ERAS; Integrative medicine; Acupoint application
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• 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