Prehabilitation During Neoadjuvant Chemoradiotherapy for Rectal Cancer
Effect of Prehabilitation on Rectal Cancer Surgery Following Neoadjuvant Chemoradiotherapy: A Randomized Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Zhongshan Hospital Fudan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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Physical exercises personally scheduled consisting of daily aerobic exercise(30mins) of fast walking(≥5km) and resisitance training.
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
Relaxation exercise and psychological counselling delivered by weekly telephone follow-up
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No Intervention: Standard care
Patients receive no specific interventions mentioned above during their neoadjuvant chemoradiotherapy.
All patients undergoing primary leision resection will receive postoperative ERAS care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional outcome
Time Frame: at baseline, before surgery, 4 weeks and 8 weeks after surgery
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Walking capacity measured by 6-minute walking distance (6MWD)
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at baseline, before surgery, 4 weeks and 8 weeks after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
perioperative complication
Time Frame: recorded from the day of surgery to 30 days after surgery
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measured by comprehensive complication index (CCI)
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recorded from the day of surgery to 30 days after surgery
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Nutrition status
Time Frame: at baseline, before surgery, 4 and 8 weeks after discharge
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measured by BMI and SMI
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at baseline, before surgery, 4 and 8 weeks after discharge
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Patient-reported outcome measures
Time Frame: at baseline, before surgery and 30days after discharge
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using SF-36
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at baseline, before surgery and 30days after discharge
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immune function markers
Time Frame: at baseline, before surgery, 4 and 8 weeks after discharge
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specific immnue cells like CD4/CD8, cytokines, peripheral blood test.
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at baseline, before surgery, 4 and 8 weeks after discharge
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Xu Jianmin, MD, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- preHab-rectal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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