NCT04749381

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

2.3 years

First QC Date

October 9, 2020

Last Update Submit

February 10, 2021

Conditions

Rectal Cancer

Keywords

ERASIntegrative medicineAcupoint applicationComplianceQuality of life

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Rates of the complications after curative surgery

    from operation to 30 days after operation

Secondary Outcomes (5)

  • recovery of urinary function

    from removal of urinary catheter to 30 days after operation

  • Recovery of fart and bowel function

    7 days after operation

  • The European Organization of Quality of Life Questionnaire-colorectal-29

    30 days after operation

  • Changes of TCM symptoms

    30 days after operation

  • Length of hospital stay

    30 days after operation

Study Arms (2)

TCM group

EXPERIMENTAL

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

Combination Product: acupoint with TCM

Control group

PLACEBO COMPARATOR

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

Combination Product: acupoint with placebo

Interventions

acupoint with TCMCOMBINATION_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.

TCM group
acupoint with placeboCOMBINATION_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.

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsPatient Compliance

Interventions

Acupuncture Points

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

MeridiansAcupuncture TherapyComplementary TherapiesTherapeutics

Study Officials

  • Aiwen Wu, M.D.

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

  • Xiaoqiang Jia, M.D.;Ph.D

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Chen, M.D.;Ph.D

CONTACT

+86 18911956939chennanpku@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients enrolled are randomized into acupoint application group and placebo acupoint application group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute

Study Record Dates

First Submitted

October 9, 2020

First Posted

February 11, 2021

Study Start

September 28, 2020

Primary Completion

December 30, 2022

Study Completion

February 20, 2023

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

CN(1)