ONCO-RET: Supervised Resistance Training During Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Strength training program.
- Who it may be relevant to
- Registry conditions: Locally Advanced Rectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Recruitment rate (enrolled among eligible patients) (%) [Time frame: During the recruitment period]
- Retention rate (participants completing the intervention) (%) [Time frame: 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)]
- Participants completing ≥80% of planned supervised sessions (%) [Time frame: 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)]
Secondary outcome measures (1)
- Participants with ≥1 exercise-related adverse event (CTCAE v6.0) (%) [Time frame: From enrollment through end of intervention (24 weeks)]
Eligibility criteria
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%).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Chile · 1 center
- Fundación Arturo López Pérez — Santiago
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 T PMID 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. PMID 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. PMID 29936624
Identifiers
NCT: NCT07453173 · INT048 · INT048