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

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
acupoint with TCM
acupoint with placebo
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Cancer focused on measuring ERAS, Integrative medicine, Acupoint application, Compliance, Quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TCM group

Control group

Arm Description

Rectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine.

Rectal cancer patients randomized to this group will have acupoint application with placebo .

Outcomes

Primary Outcome Measures

Postoperative complications
Rates of the complications after curative surgery

Secondary Outcome Measures

recovery of urinary function
The rates of urinary retention after removal of urinary catheter
Recovery of fart and bowel function
The time of the first tart and first defecation after operation in days
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.
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.
Length of hospital stay
Time of hospital stay in days

Full Information

First Posted
October 9, 2020
Last Updated
February 10, 2021
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04749381
Brief Title
The Role of TCM on ERAS of Rectal Cancer Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
February 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
ERAS, Integrative medicine, Acupoint application, Compliance, Quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients enrolled are randomized into acupoint application group and placebo acupoint application group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TCM group
Arm Type
Experimental
Arm Description
Rectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Rectal cancer patients randomized to this group will have acupoint application with placebo .
Intervention Type
Combination Product
Intervention Name(s)
acupoint with TCM
Intervention Description
The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.
Intervention Type
Combination Product
Intervention Name(s)
acupoint with placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative complications
Description
Rates of the complications after curative surgery
Time Frame
from operation to 30 days after operation
Secondary Outcome Measure Information:
Title
recovery of urinary function
Description
The rates of urinary retention after removal of urinary catheter
Time Frame
from removal of urinary catheter to 30 days after operation
Title
Recovery of fart and bowel function
Description
The time of the first tart and first defecation after operation in days
Time Frame
7 days after operation
Title
The European Organization of Quality of Life Questionnaire-colorectal-29
Description
Cancer Quality of Life Questionnaire-Colorectal-29, with scale from 1 to 4 for each items as QOL becomes poorer.
Time Frame
30 days after operation
Title
Changes of TCM symptoms
Description
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.
Time Frame
30 days after operation
Title
Length of hospital stay
Description
Time of hospital stay in days
Time Frame
30 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Chen, M.D.;Ph.D
Phone
+86 18911956939
Email
chennanpku@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiwen Wu, M.D.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Jia, M.D.;Ph.D
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Chen, M.D.;Ph.D.
Phone
+86 18911956939
Email
chennanpku@126.com
First Name & Middle Initial & Last Name & Degree
Aiwen Wu, M.D
First Name & Middle Initial & Last Name & Degree
Nan Chen, M.D.;Ph.D.

12. IPD Sharing Statement

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The Role of TCM on ERAS of Rectal Cancer Patients

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