NCT Number: NCT07453173
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Santiago, Santiago Metropolitan, 7500921, Chile
Claudia C Chavez, Master of Science in Biostatis
CONTACT
Gabriel N Marzuca, kinesiologist
PRINCIPAL_INVESTIGATOR
Macarena B Artigas, kinesiologist
CONTACT
Macarena B Artigas, kinesiologist
SUB_INVESTIGATOR
Nicole M Caire, Medical Oncologist
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individualized supervised progressive resistance training twice weekly (60 minutes/session) from start of neoadjuvant therapy to surgery (24 weeks), with loads prescribed from baseline strength testing and progressed every 2 weeks; safety monitored and adapted based on clinical status.
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.
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.
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%
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.
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.
Time frame: From enrollment through end of intervention (24 weeks)
Safety will be assessed as the proportion of participants experiencing ≥1 exercise-related adverse event during the intervention period. Exercise-related adverse events will be classified and graded using CTCAE v6.0.
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Description:
Cross-sectional muscle area (CSA) at lumbar level L3 will be quantified using routine CT (thorax-abdomen-pelvis) at baseline and pre-surgery. Change from baseline will be analyzed.
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Handgrip strength will be measured using a handgrip dynamometer at baseline and post-prehabilitation. Change from baseline will be analyzed.
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Physical performance will be measured using the Short Physical Performance Battery (SPPB). Change from baseline will be analyzed.
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Quality of life will be measured using the EORTC QLQ-C30 questionnaire. Scores range from 0 to 100. Change from baseline will be analyzed.Unit of Measure:
Score (0-100)
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Fatigue will be measured using the Brief Fatigue Inventory (BFI). Scores range from 0 to 10. Change from baseline will be analyzed.
Time frame: End of intervention (prior to surgery; ~24 weeks)
Satisfaction will be assessed using the Client Satisfaction Questionnaire (CSQ-8) at the end of the intervention.Unit of Measure: Score (8-32)
Contact information is provided by the study sponsor or research team.
Fundacion Arturo Lopez Perez
Other
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
Acronym: ONCO-RET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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