Exercise for improving radiotherapy efficacy in rectal cancer
Research type
Research Study
Full title
A Single arm Feasibility study of Exercise for improving short-course radiotherapy efficacy in people diagnosed with locally advanced rectal cancer.
IRAS ID
326709
Contact name
John Saxton
Contact email
Sponsor organisation
University of Hull
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 28 days
Research summary
Rectal cancer is a significant global and UK health problem causing death, disability and financial constraints to people living with this condition. As a result of improvements in current treatment approaches to rectal cancer, survival rates are higher but People with rectal cancer may live with severe morbidity and impaired quality of life.
The main curative treatment for rectal cancer remains surgical excision of cancerous tumour. Prior to surgery, chemotherapy aimed at suppressing the growth of tumour and radiotherapy, aimed at shrinking the size of tumours can be delivered separately or concurrently. This may be followed up with post-surgery(adjuvant) chemotherapy. Neoadjuvant radiotherapy (NART) have been shown to be useful for improving overall survival, pathological complete response, and reducing recurrence and metastasis of tumour. However, NART pose some risks to cancer patients from, cardiotoxicity, bleeding disorder (thrombocytopenia), nausea, loss of muscle mass, reduction in physical functioning and consequently reduction in quality of life.
To mitigate some radiotherapy induced adverse effects, some studies have looked to exercise with minimal adverse effects, antioxidant properties, potential for improving muscle mass, and physical activity, to be standard adjunct to NACRT. Exercise remains to be embedded in rectal cancer pathway, possibly because there are few studies in this field with small sample size and limited demonstration of the role of exercise in chemoradiotherapy efficacy.
We plan to study a cohort of patients with locally advanced rectal cancer prescribed short-course NART by a colorectal multidisciplinary team (MDT) in our NHS trust. To determine the feasibility, tolerability, and safety of an exercise programme during NART. Additionally, we explore the role of a structured exercise program on NART efficacy. We propose to investigate this by conducting a single arm feasibility study.
Summary of results
This study aimed to assess whether it was possible to involve people with locally advanced rectal cancer in a structured exercise program before, during and after short-course neoadjuvant radiotherapy.
The study also aimed to explore whether exercise might improve:
• How well the cancer treatment works, and
• Patients’ quality of life (their physical, emotional and social wellbeing).
What would the exercise program have involved?
The planned program would have lasted seven weeks and included:
• Supervised hospital-based exercise twice per week.
• Vigorous aerobic interval training (short bursts of higher-intensity exercise with recovery periods), tailored to each person’s heart rate reserves.
• Supported strength (resistance) exercises at home twice per week.
During the week of radiotherapy, participants would have completed exercise sessions shortly before each treatment session.
Who took part?
No participants were recruited.
Although patients were screened, only two met the eligibility criteria within the available timeframe. None of the two eligible patients agreed to participate in the study, as a result, no patients were enrolled in the study.
What were the results?
Because no participants were recruited, it was not possible to assess:
• Whether the exercise program was feasible,
• Whether it affected treatment outcomes, or
• Whether it improved quality of life.
No safety concerns arose, as no participants took part.
Conclusion
In this setting, it was not feasible to recruit enough patients to deliver the planned exercise program. Although the study did not proceed to enrolment, it has provided useful information about the practical challenges of conducting exercise research alongside this specific cancer treatment pathway.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
24/YH/0084
Date of REC Opinion
28 May 2024
REC opinion
Further Information Favourable Opinion