Clinical trial NCT06542354: Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer
Official title: Effect of Prehabilitation on Rectal Cancer Surgery Following Neoadjuvant Chemoradiotherapy: A Randomized Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: prehabilitation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Functional outcome
timeFrame: at baseline, before surgery, 4 weeks and 8 weeks after surgery
Secondary outcomes:
measure: perioperative complication
timeFrame: recorded from the day of surgery to 30 days after surgery
measure: Nutrition status
timeFrame: at baseline, before surgery, 4 and 8 weeks after discharge
measure: Patient-reported outcome measures
timeFrame: at baseline, before surgery and 30days after discharge
measure: immune function markers
timeFrame: at baseline, before surgery, 4 and 8 weeks after discharge
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xu Jianmin, MD
role: STUDY_DIRECTOR
References: