The Role of Traditional Chinese Medicine on Enhanced Recovery After Surgery for Patients With Rectal Cancer Undergoing Curative Surgery: A Randomized Controlled Trial
| Registry | NCT04749381, acronym RCT |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 264 (Estimated) |
| Sponsor | Peking University Cancer Hospital & Institute (Other) |
| Conditions | Rectal Cancer |
| Interventions | acupoint with TCM, acupoint with placebo (Combination product) |
| Dates | start 2020-09-28, primary completion 2022-12-30 (estimated), completion 2023-02-20 (estimated), first posted 2021-02-11, last updated 2021-02-11 |
| Locations | 1 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
This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TCM group | Experimental | Combination Product: acupoint with TCM | Rectal cancer patients randomized to this group will have acupoint application with traditional Chinese medicine. |
| Control group | Placebo comparator | Combination Product: acupoint with placebo | Rectal cancer patients randomized to this group will have acupoint application with placebo . |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing, Beijing Municipality | China | Recruiting |