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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Recruitment rate (enrolled among eligible patients) (%) [Срок оценки: During the recruitment period]
• Retention rate (participants completing the intervention) (%) [Срок оценки: From enrollment through end of intervention (~24 weeks)]
• Mean adherence to planned supervised resistance-training sessions (%) [Срок оценки: From enrollment through end of intervention (~24 weeks)]
• Participants completing ≥80% of planned supervised sessions (%) [Срок оценки: From enrollment through end of intervention (~24 weeks)]
• Data completeness (completed scheduled assessments among planned assessments) (%) [Срок оценки: From enrollment through end of intervention (~24 weeks)]

Вторичные конечные точки (1)

• Participants with ≥1 exercise-related adverse event (CTCAE v6.0) (%) [Срок оценки: From enrollment through end of intervention (24 weeks)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Чили · 1 центр

• Fundación Arturo López Pérez — Santiago

Публикации

• 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

Идентификаторы

NCT: NCT07453173 · INT048 · INT048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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