The Role of TCM on ERAS of Rectal Cancer Patients

Rectal Cancer Clinical Trial

— RCT  

Official title:

The Role of Traditional Chinese Medicine on Enhanced Recovery After Surgery for Patients With Rectal Cancer Undergoing Curative Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749381
• Other study ID #: PKUCH-R06
• Status: Recruiting
• Phase: Phase 2
• Start date: September 28, 2020
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2021
• Source: Beijing Cancer Hospital
• Contact: Nan Chen, M.D.;Ph.D
• Phone: +86 18911956939
• Email: chennanpku[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: February 20, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Rates of the complications after curative surgery	from operation to 30 days after operation
Secondary	recovery of urinary function	The rates of urinary retention after removal of urinary catheter	from removal of urinary catheter to 30 days after operation
Secondary	Recovery of fart and bowel function	The time of the first tart and first defecation after operation in days	7 days after operation
Secondary	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
Secondary	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
Secondary	Length of hospital stay	Time of hospital stay in days	30 days after operation