Exercise to enhance radiotherapy effectiveness in rectal cancer patients
A Single Arm Feasibility Study of Exercise for Improving Short-course Radiotherapy Efficacy in People Diagnosed with Locally Advanced Rectal Cancer
This study is testing if a 7-week exercise program can make radiotherapy work better for people with locally advanced rectal cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Hull Academic / other |
| Locations | 1 site (Hull, East Yorkshire) |
| Trial ID | NCT06292975 on ClinicalTrials.gov |
What this trial studies
This feasibility study investigates the impact of a structured 7-week exercise program on the efficacy of short-course neoadjuvant radiotherapy in patients diagnosed with locally advanced rectal cancer. Participants will engage in supervised vigorous intensity aerobic interval exercise and resistance training before, during, and after their radiotherapy treatment. The study aims to recruit up to 30 patients from Castle Hill Hospital, with follow-up assessments conducted over a 6-month period post-treatment to evaluate outcomes. The research team will ensure that participants are well-informed and consent to the study before participation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with locally advanced rectal cancer who are able to participate in an exercise program.
Not a fit: Patients with severe psychiatric disorders, metastatic cancer, or significant movement deficiencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with locally advanced rectal cancer undergoing radiotherapy.
How similar studies have performed: While exercise interventions in cancer treatment are gaining interest, this specific approach in conjunction with radiotherapy for rectal cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 short-course neoadjuvant radiotherapy 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.
Where this trial is running
Hull, East Yorkshire
- Castle Hill Hospital — Hull, East Yorkshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: John Saxton — University of Hull
- Study coordinator: Chizitara Amadi, BHSc
- Email: CHIZITARA.AMADI-2021@hull.ac.uk
- Phone: 07887391904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.