A Pilot, Single-Arm, Prospective Study Assessing Feasibility and Safety of a Supervised Progressive Resistance Training Program During Total NeoadjuvantTherapy (RAPIDO) Until Surgery in Locally Advanced Rectal Cancer
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fundacion Arturo Lopez Perez
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Recruitment rate (enrolled among eligible patients) (%)
Overview
Brief Summary
Colorectal cancer is a major cause of cancer death in Chile. Many people with rectal cancer that has grown into nearby tissues receive chemotherapy and radiation before surgery. These treatments can cause tiredness and loss of muscle, which may make it harder for patients to complete treatment.
This study will look at whether a supervised strength-training exercise program is practical and safe during treatment before surgery. Participants will do a personalized strength-training program two times per week. The program will start when cancer treatment begins and will continue until surgery (about 24 weeks).
The study will measure how practical the program is by looking at how many people join the study, stay in the study, and attend the exercise sessions, and whether the study team can collect all planned information. The study will also track any problems or side effects related to exercise.
The study will also explore whether the exercise program may help maintain muscle, improve strength and physical function, improve quality of life, reduce fatigue, and affect how the tumor responds to treatment. These results will be compared with information from similar patients previously treated at the same hospital.
Detailed Description
Eligible patients with locally advanced rectal adenocarcinoma treated at FALP and scheduled for RAPIDO total neoadjuvant therapy will be invited during routine visits.
Participants receive usual oncologic care plus a supervised, individualized resistance training program performed in the FALP Kinesiology Service gym. Each session lasts 60 minutes, twice weekly, from the start of neoadjuvant therapy to surgery (24 weeks).
Training loads are prescribed from baseline strength testing and progressed every 2 weeks; an intermediate clinical-functional assessment around week 8 supports safe adjustment. Assessments occur at baseline and within 48 hours before surgery. Data will be stored in REDCap.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Locally advanced rectal adenocarcinoma planned for RAPIDO total neoadjuvant therapy (short-course RT + chemotherapy + surgery), meeting protocol staging criteria (e.g., cT3N1/cT4/cN2/EMVI+/threatened mesorectal fascia/lateral pelvic disease).
Exclusion Criteria
- •Metastatic disease at diagnosis.
- •Severe/uncontrolled cardiovascular disease (ejection fraction \<50%).
Arms & Interventions
Supervised Progressive Resistance Training
Participants receive supervised, individualized progressive resistance training twice weekly (60 minutes/session) from start of neoadjuvant therapy until surgery (24 weeks).
Intervention: Strength training program (Other)
Outcomes
Primary Outcomes
Recruitment rate (enrolled among eligible patients) (%)
Time Frame: During the recruitment period
Primary Outcome Measure 1 - Recruitment Recruitment will be calculated as: (number of eligible patients who enroll ÷ number of eligible patients approached) × 100. The feasibility threshold is ≥60% of eligible patients agreeing to participate.
Retention rate (participants completing the intervention) (%)
Time Frame: From enrollment through end of intervention (~24 weeks)
Description: Retention will be calculated as: (number of enrolled participants who complete the intervention ÷ number enrolled) × 100. The feasibility threshold is ≥80% completing the intervention.
Mean adherence to planned supervised resistance-training sessions (%)
Time Frame: From enrollment through end of intervention (~24 weeks)
Adherence (individual-level) will be calculated as: (number of supervised sessions completed ÷ number of planned sessions) × 100. Study-level adherence will be reported as the mean of individual adherence percentages across all enrolled participants. Planned dose: 2 supervised sessions/week from start of neoadjuvant therapy until surgery (\~24 weeks; total 48 sessions). The feasibility threshold is mean adherence ≥80%
Participants completing ≥80% of planned supervised sessions (%)
Time Frame: From enrollment through end of intervention (~24 weeks)
A participant will be considered adherent if they complete ≥80% of planned supervised sessions (≥39 of 48 sessions). The proportion of participants meeting this threshold will be calculated. The feasibility threshold is ≥75% of participants completing ≥80% of planned sessions.
Data completeness (completed scheduled assessments among planned assessments) (%)
Time Frame: From enrollment through end of intervention (~24 weeks)
Data completeness will be calculated as: (number of completed scheduled assessments ÷ number of planned assessments) × 100. The feasibility threshold is ≥85% of scheduled assessments completed.
Secondary Outcomes
- Participants with ≥1 exercise-related adverse event (CTCAE v6.0) (%)(From enrollment through end of intervention (24 weeks))