Exercise to enhance chemoradiotherapy effectiveness in advanced rectal cancer patients
A Single Arm Feasibility Study of Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer
This study is testing if an 11-week exercise program can help people with advanced rectal cancer get better results from their chemoradiotherapy treatment.
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 (Cottingham, East Yorkshire) |
| Trial ID | NCT06276686 on ClinicalTrials.gov |
What this trial studies
This feasibility study involves a single arm approach where patients diagnosed with locally advanced rectal cancer will participate in an 11-week structured exercise program consisting of vigorous intensity aerobic interval exercise and resistance training. The program is designed to be implemented before, during, and after their neoadjuvant chemoradiotherapy treatment. A total of 30 patients will be recruited from Castle Hill Hospital, and their progress will be monitored over a 6-month follow-up period post-treatment. The study aims to assess the impact of exercise on the efficacy of chemoradiotherapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with locally advanced rectal cancer who are scheduled to receive long-course neoadjuvant chemoradiotherapy.
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 undergoing chemoradiotherapy for locally advanced rectal cancer.
How similar studies have performed: While the specific combination of exercise and chemoradiotherapy in this context is novel, similar studies have shown positive outcomes with exercise interventions in cancer treatment.
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 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.
Where this trial is running
Cottingham, East Yorkshire
- Castle Hill Hospital — Cottingham, East Yorkshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Chizitara Amadi
- 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.