Clinical trial · Interventional
Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer
A Single Arm Feasibility Study of Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer
NCT06276686CI-TRIAL-00085465recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm feasibility study of exercise for improving long- course neoadjuvant chemoradiotherapy (NACRT) efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patients will be provided with an 11-week course of structured aerobic exercises and resistance training in the periods before, during and after their chemoradiotherapy treatment. The patients will be followed up for 6 months post long course neoadjuvant chemoradiotherapy (NACRT), with a total of 3 assessment periods.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Carcinoma | Rectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supervised Vigorous intensity aerobic interval exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm feasibility
- description
- This study involves a single arm only. Therefore all consenting participants will receive the exercise intervention detailed in the protocol. The exercise interventions include an 11-week aerobic and resistance training delivered 2-weeks before chemoradiotherapy commences , in the 5-weeks of chemoradiotherapy and 4 weeks following chemoradiotherapy. 2-days Aerobic exercise will be delivered on vigorous intensity on a cycle ergometer. This will be under the supervision of a trained physiotherapist. 2-days Resistance training will be home based with guidance of an exercise sheet.
- interventionNames
- Other: Supervised Vigorous intensity aerobic interval exercise
Primary outcomes (3)
- measure
- Recruitment rate
- timeFrame
- This will be monitored in the total 6months of participants engagement if the study
- description
- The number of recruited participants/ total number of patients approached in percentage.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * Have been diagnosed with locally advanced rectal cancer using MRI (Magnetic Resonance Imaging) and histological finding * Have been offered long-course neoadjuvant chemoradiotherapy in the Queens Centre, Castle Hill Hospital * Willing and able to comply with all study requirements * Able and willing to voluntarily give informed consent to take part. Exclusion Criteria: * Inability to understand basic written and spoken English, as research materials will all be written in English. * Any movement deficiencies limiting ability to engage in exercise. * Impaired cognition and/or capacity limiting ability to provide informed consent. * Cardiovascular and/or cardiopulmonary conditions that will impede ability to safely perform exercise. * Severe psychiatric disorders. * With any other health condition which oncologists and research team agrees will impede ability to safely perform exercises. * Presence of metastatic cancer.
References
Publications (5)
- BACKGROUNDChen T, Zhu H, Su Q. Effectiveness and Safety of Four Aerobic Exercise Intensity Prescription Techniques in Rehabilitation Training for Patients with Coronary Heart Disease. Cardiol Res Pract. 2022 Jul 15;2022:1647809. doi: 10.1155/2022/1647809. eCollection 2022. PMID 35874554
- BACKGROUNDDwyer CP, Moses A, Rogers FM, Casey D, Joyce R, Hynes SM. A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial. J Health Psychol. 2023 Mar;28(4):374-387. doi: 10.1177/13591053211037736. Epub 2021 Aug 6. PMID 34355599
- BACKGROUNDAlejo 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
- BACKGROUNDLoughney 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. PMID 34154675
- BACKGROUNDMoug 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