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

NCT07453173 | Not Yet Recruiting

• 1 other identifier: INT048
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Cancer

Keywords

prehabilitation; resistance training; total neoadjuvant therapy; RAPIDO; feasibility; safety

Outcome Measures

Primary Outcomes (5)

• Recruitment rate (enrolled among eligible patients) (%)

  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) (%)

  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 (%)

  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 (%)

  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) (%)

  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 Outcomes (1)

• Participants with ≥1 exercise-related adverse event (CTCAE v6.0) (%)

  From enrollment through end of intervention (24 weeks)

Other Outcomes (6)

• Change from baseline in cross-sectional skeletal muscle area at L3 measured by CT (cm²)

  Baseline and within 48 hours prior to rectal surgery (~24 weeks)

• Change from baseline in handgrip strength measured by dynamometer (kg)

  Baseline and within 48 hours prior to rectal surgery (~24 weeks)

• Change from baseline in Short Physical Performance Battery (SPPB) score (points)

  Baseline and within 48 hours prior to rectal surgery (~24 weeks)

Study Arms (1)

Supervised Progressive Resistance Training

EXPERIMENTAL

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

Interventions

Strength training program OTHER

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.

Supervised Progressive Resistance Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Metastatic disease at diagnosis.
• Severe/uncontrolled cardiovascular disease (ejection fraction \<50%).

Sponsors & Collaborators

• Fundacion Arturo Lopez Perez: lead

Study Sites (1)

Fundación Arturo López Pérez

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Related Publications (22)

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Central Study Contacts

Nicole M Caire, Medical Oncologist

CONTACT

+56974998222; nicole.caire@falp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm pilot study to mesure feasibility and safety of the intervention : a excercise program during the neoadjuvant treatment in patients with locally advaced rectal cancer

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: March 5, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From March 2026 to March 2031
• Access Criteria: Research team using an institucional RedCap platform

Locations

CL (1)