Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Behavioral: Physical exercise; Dietary Supplement: Nutrition supplement; Behavioral: Mental support

• Registration Number: NCT06542354
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2022-01-17
• Primary Completion: 2023-12-30
• Study Completion: 2024-03-20
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-04
• Last Update Submitted: 2024-08-04
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Mental support	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.
Prehabilitation	Physical exercise	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.
Prehabilitation	Nutrition supplement	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.

Primary Outcome Measures

Name	Time	Method
Functional outcome	at baseline, before surgery, 4 weeks and 8 weeks after surgery	Walking capacity measured by 6-minute walking distance (6MWD)

Secondary Outcome Measures

Name	Time	Method
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.
perioperative complication	recorded from the day of surgery to 30 days after surgery	measured by comprehensive complication index (CCI)

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China