Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer

Fudan University

Status: Completed

Conditions: Rectal Cancer

Treatments: Dietary Supplement: Nutrition supplement; Behavioral: Physical exercise; Behavioral: Mental support

Study type: Interventional

Funder types: Other

Identifiers

NCT06542354

preHab-rectal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Prehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Mental support

Behavioral: Physical exercise

Dietary Supplement: Nutrition supplement

Standard care

No Intervention group

Description:

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