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Locally Advanced Rectal CancerONCO-RETNCT07453173

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

A study testing Strength training program in people with Locally Advanced Rectal Cancer, run by Fundacion Arturo Lopez Perez at 1 site in Chile.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Locally Advanced Rectal Cancer
What is being tested?
Strength training program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChile
Study dates
9 Mar 2026to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicole M Caire, Medical Oncologist contact

+56974998222

nicole.caire@falp.org

Chile1 site
  • Fundación Arturo López Pérez

    Santiago, Santiago Metropolitan, 7500921

    Claudia C Chavez, Master of Science in Biostatis, +56 9 6617 2416, claudia.chavezo@falp.org

    Macarena B Artigas, kinesiologist, +56990420698, macarena.artigas@falp.org

Other trials in Chile

About this study

Official title: 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).

Read more

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.

Read the 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.

Being tested
Strength training program
Keywords
prehabilitation; resistance training; total neoadjuvant therapy; RAPIDO; feasibility; safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength training programOther

    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.

Study groups in NCT07453173
Study groupRoleWhat they receive
Supervised Progressive Resistance TrainingExperimentalParticipants receive supervised, individualized progressive resistance training twice weekly (60 minutes/session) from start of neoadjuvant therapy until surgery (24 weeks).
Receives: Other: Strength training program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the recruitment period

  2. 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.

    Measured: From enrollment through end of intervention (~24 weeks)

  3. 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%

    Measured: From enrollment through end of intervention (~24 weeks)

  4. 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.

    Measured: From enrollment through end of intervention (~24 weeks)

  5. 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.

    Measured: From enrollment through end of intervention (~24 weeks)

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

    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.

    Measured: From enrollment through end of intervention (24 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start9 Mar 2026 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07453173
Sponsor's protocol ID
INT048
Other IDs
INT048
Acronym
ONCO-RET
Status last verified
Feb 2026
First submitted
21 Jan 2026
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Recruitment rate, Mean Adherence and Safety profile

Publications

  • Singh B, Hayes SC, Spence RR, Steele ML, Millet GY, Gergele L. Exercise and colorectal cancer: a systematic review and meta-analysis of exercise safety, feasibility and effectiveness. Int J Behav Nutr Phys Act. 2020 Sep 24;17(1):122. doi: 10.1186/s12966-020-01021-7.

    PubMed 32972439
  • Latrille M, Buchs NC, Ris F, Koessler T. Physical activity programmes for patients undergoing neo-adjuvant chemoradiotherapy for rectal cancer: A systematic review and meta-analysis. Medicine (Baltimore). 2021 Dec 23;100(51):e27754. doi: 10.1097/MD.0000000000027754.

    PubMed 34941028
  • Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Joseph K, Nijjar T, Fairchild A, Courneya KS. Feasibility, Safety, and Preliminary Efficacy of Exercise During and After Neoadjuvant Rectal Cancer Treatment: A Phase II Randomized Controlled Trial. Clin Colorectal Cancer. 2021 Sep;20(3):216-226. doi: 10.1016/j.clcc.2021.05.004. Epub 2021 May 26.

    PubMed 34158253
  • Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Nijjar T, Joseph K, Fairchild A, Courneya KS. Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial. Trials. 2018 Jan 12;19(1):35. doi: 10.1186/s13063-017-2398-1.

    PubMed 29329555
  • Alejo LB, Pagola-Aldazabal I, Fiuza-Luces C, Huerga D, de Torres MV, Verdugo AS, Ortega Solano MJ, Felipe JL, Lucia A, Ruiz-Casado A. Exercise prehabilitation program for patients under neoadjuvant treatment for rectal cancer: A pilot study. J Cancer Res Ther. 2019 Jan-Mar;15(1):20-25. doi: 10.4103/jcrt.JCRT_30_17.

    PubMed 30880749
  • Loughney L, West MA, Moyses H, Bates A, Kemp GJ, Hawkins L, Varkonyi-Sepp J, Burke S, Barben CP, Calverley PM, Cox T, Palmer DH, Mythen MG, Grocott MPW, Jack S; Fit4Surgery group. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER Trial). Perioper Med (Lond). 2021 Jun 22;10(1):23. doi: 10.1186/s13741-021-00190-8.

    PubMed 34154675
  • Moug SJ, Mutrie N, Barry SJE, Mackay G, Steele RJC, Boachie C, Buchan C, Anderson AS. Prehabilitation is feasible in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy and may minimize physical deterioration: results from the REx trial. Colorectal Dis. 2019 May;21(5):548-562. doi: 10.1111/codi.14560. Epub 2019 Feb 16.

    PubMed 30657249
  • Cave J, Paschalis A, Huang CY, West M, Copson E, Jack S, Grocott MPW. A systematic review of the safety and efficacy of aerobic exercise during cytotoxic chemotherapy treatment. Support Care Cancer. 2018 Oct;26(10):3337-3351. doi: 10.1007/s00520-018-4295-x. Epub 2018 Jun 24.

    PubMed 29936624
  • Campbell KL, Zadravec K, Bland KA, Chesley E, Wolf F, Janelsins MC. The Effect of Exercise on Cancer-Related Cognitive Impairment and Applications for Physical Therapy: Systematic Review of Randomized Controlled Trials. Phys Ther. 2020 Mar 10;100(3):523-542. doi: 10.1093/ptj/pzz090.

    PubMed 32065236
  • Chen X, Zhang J, Gao F, Liu N, Du H, Li J, Li Z, Chen R. Exercise therapy: an effective approach to mitigate the risk of cancer metastasis. World J Surg Oncol. 2025 May 16;23(1):192. doi: 10.1186/s12957-025-03846-7.

    PubMed 40380237
  • Bland KA, Zadravec K, Landry T, Weller S, Meyers L, Campbell KL. Impact of exercise on chemotherapy completion rate: A systematic review of the evidence and recommendations for future exercise oncology research. Crit Rev Oncol Hematol. 2019 Apr;136:79-85. doi: 10.1016/j.critrevonc.2019.02.005. Epub 2019 Feb 16.

    PubMed 30878132
  • Zaorsky NG, Allenby T, Lin J, Rosenberg J, Simone NL, Schmitz KH. Exercise Therapy and Radiation Therapy for Cancer: A Systematic Review. Int J Radiat Oncol Biol Phys. 2021 Jul 15;110(4):973-983. doi: 10.1016/j.ijrobp.2020.11.024. Epub 2020 Nov 19.

    PubMed 33220396
  • Yang L, Morielli AR, Heer E, Kirkham AA, Cheung WY, Usmani N, Friedenreich CM, Courneya KS. Effects of Exercise on Cancer Treatment Efficacy: A Systematic Review of Preclinical and Clinical Studies. Cancer Res. 2021 Oct 1;81(19):4889-4895. doi: 10.1158/0008-5472.CAN-21-1258. Epub 2021 Jul 2.

    PubMed 34215623
  • Ashcraft KA, Warner AB, Jones LW, Dewhirst MW. Exercise as Adjunct Therapy in Cancer. Semin Radiat Oncol. 2019 Jan;29(1):16-24. doi: 10.1016/j.semradonc.2018.10.001.

    PubMed 30573180
  • Wang Q, Zhou W. Roles and molecular mechanisms of physical exercise in cancer prevention and treatment. J Sport Health Sci. 2021 Mar;10(2):201-210. doi: 10.1016/j.jshs.2020.07.008. Epub 2020 Jul 30.

    PubMed 32738520

Questions about this trial

What is this clinical trial studying?

A study testing Strength training program in people with Locally Advanced Rectal Cancer, run by Fundacion Arturo Lopez Perez at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicole M Caire, Medical Oncologist (+56974998222, nicole.caire@falp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (enrolled among eligible patients) (%) (time frame: During the recruitment period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07453173, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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