Clinical trial NCT04749381: The Role of TCM on ERAS of Rectal Cancer Patients
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: ERAS
Integrative medicine
Acupoint application
Compliance
Quality of life
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients enrolled are randomized into acupoint application group and placebo acupoint application group
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Postoperative complications
timeFrame: from operation to 30 days after operation
Secondary outcomes:
measure: recovery of urinary function
timeFrame: from removal of urinary catheter to 30 days after operation
measure: Recovery of fart and bowel function
timeFrame: 7 days after operation
measure: The European Organization of Quality of Life Questionnaire-colorectal-29
timeFrame: 30 days after operation
measure: Changes of TCM symptoms
timeFrame: 30 days after operation
measure: Length of hospital stay
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Aiwen Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Xiaoqiang Jia, M.D.;Ph.D
role: PRINCIPAL_INVESTIGATOR
References: