Rectal Cancer
Conditions
Keywords
prehabilitation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPhysical exercise
Physical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training.
DIETARY_SUPPLEMENTNutrition 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
BEHAVIORALMental support
Relaxation exercise and psychological counselling delivered by weekly telephone follow-up
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with rectal cancer undergoing/scheduled for neoadjuvant chemoradiotherapy * Fried Frailty score≥2 (intermediately frail or frail) * Written consent informed
Exclusion criteria
* Co-morbiditie contraindicating physical exercise or causing disturbances of conciousness (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants) * Emergent surgery * ASA grade IV-V * Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding * Known drug abuse/ alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome | at baseline, before surgery, 4 weeks and 8 weeks after surgery | Walking capacity measured by 6-minute walking distance (6MWD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| perioperative complication | recorded from the day of surgery to 30 days after surgery | measured by comprehensive complication index (CCI) |
| Nutrition status | at baseline, before surgery, 4 and 8 weeks after discharge | measured by BMI and SMI |
| Patient-reported outcome measures | at baseline, before surgery and 30days after discharge | using SF-36 |
| immune function markers | at baseline, before surgery, 4 and 8 weeks after discharge | specific immnue cells like CD4/CD8, cytokines, peripheral blood test. |
Countries
China
Outcome results
None listed