Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer

NCT ID: NCT06542354

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2024-03-20

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Prehabilitation

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.

Group Type: EXPERIMENTAL

Physical exercise

Intervention Type: BEHAVIORAL

Physical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training.

Nutrition supplement

Intervention Type: 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

Intervention Type: BEHAVIORAL

Relaxation exercise and psychological counselling delivered by weekly telephone follow-up

Standard care

Patients receive no specific interventions mentioned above during their neoadjuvant chemoradiotherapy. All patients undergoing primary leision resection will receive postoperative ERAS care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical exercise

Physical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training.

Intervention Type: BEHAVIORAL

Nutrition 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

Intervention Type: DIETARY_SUPPLEMENT

Mental support

Relaxation exercise and psychological counselling delivered by weekly telephone follow-up

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xu Jianmin, MD

Role: STUDY_DIRECTOR

Fudan University

Locations

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

preHab-rectal

Identifier Type: -

Identifier Source: org_study_id