Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID06276686

A Single Arm Feasibility Study of Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer

Led by University of Hull · Updated on 2025-02-04

30

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Hull

Lead Sponsor

H

Hull University Teaching Hospitals NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of an exercise program to improve the effectiveness of long-course neoadjuvant chemoradiotherapy (NACRT) in people with locally advanced rectal cancer. This early phase study plans to recruit up to 30 patients diagnosed at Castle Hill Hospital to participate in structured aerobic and resistance exercises alongside their cancer treatment. The goal is to assess whether patients can safely complete the exercise regimen and to gather initial data on quality of life and treatment response. Participants will undergo an 11-week exercise program including twice-weekly supervised vigorous aerobic interval training on a cycle ergometer and twice-weekly unsupervised resistance training at home. This exercise starts 2 weeks before NACRT, continues through the 5-week chemoradiotherapy, and extends for 4 weeks after treatment. The aerobic sessions include warm-up, interval bouts at 70-80% heart rate reserve, active rest, and cooldown, all supervised by trained staff. During the study, participants will have assessments before starting exercise, after completing the 11-week program, and again 6 months after beginning NACRT. These assessments include physical measures like BMI, questionnaires on quality of life, wearing an accelerometer to track activity, and heart rate monitoring. Researchers will also collect clinical data on tumor response and treatment outcomes. Participant feedback will be gathered through interviews to evaluate satisfaction and acceptability of the exercise program. Total participation lasts up to 7 months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Diagnosed with locally advanced rectal cancer confirmed by MRI and histology
  • Offered long-course neoadjuvant chemoradiotherapy at Queens Centre, Castle Hill Hospital
  • Willing and able to follow all study requirements
  • Able and willing to give informed consent voluntarily
Not Eligible

You will not qualify if you...

  • Unable to understand basic written and spoken English
  • Movement difficulties limiting ability to exercise
  • Impaired cognition or capacity limiting informed consent
  • Cardiovascular or cardiopulmonary conditions making exercise unsafe
  • Severe psychiatric disorders
  • Any health condition deemed unsafe for exercise by oncologists or research team
  • Presence of metastatic cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 1 week

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Baseline Assessment

Duration - 1 day

Participants undergo baseline assessments including medical history review, height and weight measurements, questionnaires on quality of life, and resting heart rate measurements. Participants are also provided an accelerometer to wear on selected days during the study.

1 baseline visit (in-person)

Exercise Intervention

Duration - 11 weeks

Participants engage in an 11-week supervised exercise program including vigorous intensity aerobic interval training twice weekly at the hospital and twice weekly supported at-home resistance training. This period spans 2 weeks before, 5 weeks during, and 4 weeks after long-course neoadjuvant chemoradiotherapy (NACRT).

Twice weekly supervised aerobic exercise sessions and twice weekly unsupervised resistance training sessions

Post-exercise Assessment

Duration - 1 day

Participants complete post-exercise assessments similar to baseline to compare changes following the exercise intervention.

1 post-exercise visit (in-person)

Post-surgery Follow-up

Duration - Approximately 6 months from NACRT start

Participants are followed up 6 months after starting neoadjuvant chemoradiotherapy to collect information on cancer response and tumor regression, and to participate in a semi-structured interview about trial satisfaction and exercise acceptability.

1 follow-up visit (in-person or via telephone)

Trial Site Locations

Total: 1 location

1

Castle Hill Hospital

Cottingham, East Yorkshire, United Kingdom, HU16 7JQ

Actively Recruiting

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Research Team

C

Chizitara Amadi

J

John Saxton

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Published Research Related To This Trial

Effectiveness and Safety of Four Aerobic Exercise Intensity Prescription Techniques in Rehabilitation Training for Patients with Coronary Heart Disease.

Tao Chen, Huiying Zhu, Qingyuan Su

https://pubmed.ncbi.nlm.nih.gov/35874554

A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial.

Christopher P Dwyer, Anusha Moses, Fionnuala M Rogers...

https://pubmed.ncbi.nlm.nih.gov/34355599

Exercise prehabilitation program for patients under neoadjuvant treatment for rectal cancer: A pilot study.

Lidia B Alejo, Itziar Pagola-Aldazabal, Carmen Fiuza-Luces...

https://pubmed.ncbi.nlm.nih.gov/30880749

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).

Lisa Loughney, Malcolm A West, Helen Moyses...

https://pubmed.ncbi.nlm.nih.gov/34154675

Prehabilitation is feasible in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy and may minimize physical deterioration: results from the REx trial.

S J Moug, N Mutrie, S J E Barry...

https://pubmed.ncbi.nlm.nih.gov/30657249