The Role of TCM on ERAS of Rectal Cancer Patients

NCT ID: NCT04749381

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2023-02-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients enrolled are randomized into acupoint application group and placebo acupoint application group
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TCM group

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

Group Type EXPERIMENTAL

acupoint with TCM

Intervention Type COMBINATION_PRODUCT

The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.

Control group

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

Group Type PLACEBO_COMPARATOR

acupoint with placebo

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Aiwen Wu

M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aiwen Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Xiaoqiang Jia, M.D.;Ph.D

Role: PRINCIPAL_INVESTIGATOR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Chen, M.D.;Ph.D

Role: CONTACT

+86 18911956939

Facility Contacts

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Nan Chen, M.D.;Ph.D.

Role: primary

+86 18911956939

Other Identifiers

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PKUCH-R06

Identifier Type: -

Identifier Source: org_study_id

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