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The purpose of this study is determine whether a trimodel prehabilitation program (combined with physical exercise, nutrition supplement and mental support) during neoadjuvant chemoradiotherapy can help patients with rectal cancer to achieve better postoperative outcomes include perioperative complication rate, functional outcomes and quality of life.
This study is a prospective, single-center, randomized control trial. Including criteria were (1) Age between 18 and 80 years; (2) Histologically confirmed rectal adenocarcinoma；(3) Performance status (ECOG) 0-2; (4) Undergoing/scheduled for neoadjuvant chemoradiotherapy lasting at least 4 weeks. (5) Fried frailty score ≥2. Patients operated as emergency, pregnant or with comodities constraining physical exercise or causing disturbance of consciousness are excluded.
All particapants were recruited and randomly assigned to receive trimodel prehabilitation program or standard care. All patients were treated with an ERAS protocol. The primary end-point is postoperative complications within 30 days. Complications were diagnosed and classified according to the Clavien-Dindo classification and comprehensive complication index was calculated. The secondary end-points were functional walking capacity, hospital length of stay, nutrition status, patient-reported health related quality of life and immune function markers. The study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University, Shanghai, China. Written informed consent was obtained for patients to participate the study. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation | Experimental | 6-week trimodel prehabilitation program consists of physical exercises, nutrition supplement and mental support for patients with rectal cancer during neoadjuvant chemotherapy before surgery. All patients will receive ERAS care pattern after surgery. |
|
| Standard care | No Intervention | Patients receive no specific interventions mentioned above during their neoadjuvant chemoradiotherapy. All patients undergoing primary leision resection will receive postoperative ERAS care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Behavioral | Physical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome | Walking capacity measured by 6-minute walking distance (6MWD) | at baseline, before surgery, 4 weeks and 8 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative complication | measured by comprehensive complication index (CCI) | recorded from the day of surgery to 30 days after surgery |
| Nutrition status | measured by BMI and SMI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xu Jianmin, MD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Nutrition supplement | Dietary Supplement | Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Oral nutrition supplement (ENSURE) is provided daily seperated in 2 doses |
|
| Mental support | Behavioral | Relaxation exercise and psychological counselling delivered by weekly telephone follow-up |
|
| at baseline, before surgery, 4 and 8 weeks after discharge |
| Patient-reported outcome measures | using SF-36 | at baseline, before surgery and 30days after discharge |
| immune function markers | specific immnue cells like CD4/CD8, cytokines, peripheral blood test. | at baseline, before surgery, 4 and 8 weeks after discharge |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |