Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer

NCT06276686 | Recruiting Early Phase 1

• 1 other identifier: RS211 - 332296
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally Advanced Rectal Carcinoma

Keywords

Exercise; chemoradiotherapy; Treatment efficacy; Locally advanced rectal cancer; Vigorous intensity aerobic interval exercise

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  The number of recruited participants/ total number of patients approached in percentage.

  This will be monitored in the total 6months of participants engagement if the study

• Attendance rate

  The number of supervised exercise sessions attended/ total number of available supervised exercise sessions in percentage.

  This will be monitored in the total 6months of participants engagement if the study

• withdrawal rate

  The number of participants who drop out of study/ total number of recruited participants in percentage.

  This will be monitored in the total 6months of participants engagement if the study

Secondary Outcomes (4)

• Serum Carcinoembryonic antigen levels

  up to 4 weeks before neoadjuvant chemoradiotherapy (NACRT), immediately following chemoradiotherapy and 6-months following NACRT

• FACT-C version 4 questionnaire for Quality of life

  up to 4 weeks before NACRT, up to 1 week post NACRT and 6-months following NACRT

• EORTC-QLQ-CR29 questionnaire for Quality of life

  up to 4 weeks before NACRT, up to 1 week post NACRT and 6-months following NACRT

• Physical activity levels

  up to 4 weeks before NACRT, up to 1 week post NACRT and 6-months following NACRT

Study Arms (1)

Single arm feasibility

EXPERIMENTAL

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.

Other: Supervised Vigorous intensity aerobic interval exercise

Interventions

Supervised Vigorous intensity aerobic interval exercise OTHER

11-weeks course of aerobic and resistance exercise, delivered 2 weeks before long course NACRT, 5-weeks during NACRT and 4 weeks post NACRT. Alongside twice weekly unsupervised resistance exercise training.

Also known as: Unsupervised resistance exercise

Single arm feasibility

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hull: lead
• Hull University Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Castle Hill Hospital

Cottingham, East Yorkshire, HU16 7JQ, United Kingdom

RECRUITING

Related Publications (5)

• Chen 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 BACKGROUND

• Dwyer 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34154675 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• John Saxton, PhD

  University of Hull

  STUDY CHAIR

Central Study Contacts

Chizitara Amadi

CONTACT

07887391904; CHIZITARA.AMADI-2021@hull.ac.uk

John Saxton

CONTACT

john.saxton@hull.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 26, 2024
• Study Start: December 10, 2024
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: February 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)