ONCO-RET: Supervised Resistance Training During Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (ONCO-RET)

March 3, 2026 updated by: Fundacion Arturo Lopez Perez

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Fundacion Arturo Lopez Perez
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicole M Caire, Medical Oncologist
        • Sub-Investigator:
          • Macarena B Artigas, kinesiologist
        • Principal Investigator:
          • Gabriel N Marzuca, kinesiologist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: Strength training program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the recruitment period
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.
From enrollment through end of intervention (~24 weeks)
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%
From enrollment through end of intervention (~24 weeks)
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.
From enrollment through end of intervention (~24 weeks)
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.
From enrollment through end of intervention (~24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with ≥1 exercise-related adverse event (CTCAE v6.0) (%)
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.
From enrollment through end of intervention (24 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in cross-sectional skeletal muscle area at L3 measured by CT (cm²)
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.
Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Change from baseline in handgrip strength measured by dynamometer (kg)
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.
Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Change from baseline in Short Physical Performance Battery (SPPB) score (points)
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.
Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Change from baseline in quality of life assessed by EORTC QLQ-C30 score (0-100)
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)
Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Change from baseline in cancer-related fatigue assessed by Brief Fatigue Inventory (BFI) score (0-10)
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.
Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Participant satisfaction with the exercise program assessed by CSQ-8 total score (8-32)
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)
End of intervention (prior to surgery; ~24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Arturo Lopez Perez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 9, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INT048 (Registry Identifier: INT048 596-MON-CRC-MUL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Recruitment rate, Mean Adherence and Safety profile

IPD Sharing Time Frame

From March 2026 to March 2031

IPD Sharing Access Criteria

Research team using an institucional RedCap platform

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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