The Role of TCM on ERAS of Rectal Cancer Patients

NCT04749381 — Phase 2, Unknown, 264 participants, Peking University Cancer Hospital & Institute

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

RegistryNCT04749381, acronym RCT
StatusUnknown
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, prevention
Enrollment264 (Estimated)
SponsorPeking University Cancer Hospital & Institute (Other)
ConditionsRectal Cancer
Interventionsacupoint with TCM, acupoint with placebo (Combination product)
Datesstart 2020-09-28, primary completion 2022-12-30 (estimated), completion 2023-02-20 (estimated), first posted 2021-02-11, last updated 2021-02-11
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Rectal Cancer All trials of acupoint with TCM All trials of acupoint with placebo

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
TCM groupExperimentalCombination Product: acupoint with TCMRectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine.
Control groupPlacebo comparatorCombination Product: acupoint with placeboRectal cancer patients randomized to this group will have acupoint application with placebo .
  • acupoint with TCM (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.
  • acupoint with placebo (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.

+Outcome measures

Primary outcomes

  • Postoperative complications [from operation to 30 days after operation]: Rates of the complications after curative surgery

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Locations (1)

FacilityCityCountryStatus
Beijing Cancer HospitalBeijing, Beijing MunicipalityChinaRecruiting

+Investigators

  • Aiwen Wu, M.D., Principal investigator, Peking University Cancer Hospital & Institute
  • Xiaoqiang Jia, M.D.;Ph.D, Principal investigator, Xiyuan Hospital of China Academy of Chinese Medical Sciences