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

Peking University Cancer Hospital & Institute

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Combination Product: acupoint with placebo; Combination Product: acupoint with TCM

Study type: Interventional

Funder types: Other

Identifiers

NCT04749381

PKUCH-R06

Details and patient eligibility

About

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

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 2 patient groups, including a placebo group

TCM group

Experimental group

Description:

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

Treatment:

Combination Product: acupoint with TCM

Control group

Placebo Comparator group

Description:

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

Treatment:

Combination Product: acupoint with placebo