Title: The clinical benefit and cost effectiveness of a gastrointestinal care bundle for patients undergoing pelvic chemoradiotherapy: A randomised controlled pilot study
Funder: Department of Health (England)

Abstract: Background 17,000 people receive pelvic radiotherapy in the UK annually19. 80% of patients are affected by gastrointestinal symptoms during pelvic radiotherapy1. Acute GI symptoms are increased with the addition of concurrent chemotherapy16,17. Severe GI symptoms are often responsible for radiotherapy treatment breaks and early cessation of chemotherapy treatment17. Overall time is important in radiotherapy3 and interruptions in treatment are associated with tumour recurrences2. Concurrent chemotherapy is increasingly used alongside pelvic radiotherapy in curative treatments. The number of cycles of chemotherapy received is associated with progression-free survival and overall survival4. Lactose intolerance (15%-44%)1,7, small bowel bacterial overgrowth (26%)1 and bile acid malabsorption (44-57%)7,8are common causes of gastrointestinal symptoms during pelvic radiotherapy. There are tests and interventions available in clinical practice to manage these diagnoses. Malnutrition is common in this patient group, affecting up to a third of people, and is a risk factor for gastrointestinal symptoms5,18. Unfortunately, gastroenterological evaluation in this setting has not been assessed. Aims The overall aim of this pilot study is to test the study design and process including recruitment and randomisation, and to provide provisional data on which to power a multicentre study to determine the effectiveness of a gastrointestinal care bundle during pelvic chemoradiotherapy for cervix and bladder cancers. Specific aims are: To determine if a gastrointestinal care bundle, including nutritional intervention and detecting and treating lactose intolerance, small bowel bacterial overgrowth and bile salt malabsorption, improves GI symptoms in the short- and long-term. To determine if this improves quality-of-life in the short- and long-term. To determine if this enables more patients to complete curative treatment with chemoradiotherapy. To determine the cost-effectiveness of implementing the gastrointestinal care bundle. To use the data to guide a change in practice across the NHS if this GI intervention is demonstrated to be of benefit to patients. Plan of Investigation Patients undergoing curative chemoradiotherapy for cervix and bladder tumours will be recruited from clinical oncology clinics at the Christie Hospital. Consenting patients will be randomised into either “treatment as usual” or “gastrointestinal care bundle”. Assessments will comprise validated patient-reported questionnaires and treatment details. Assessment points will be pre-treatment, weekly until completion of treatment (approximately 4-5 weeks), then at 6 weeks, 12 weeks and 12 months. Weekly nutritional assessments will be made in the gastrointestinal care bundle group. If nutritional problems are identified, patients will receive intervention with nutritional supplementation. If gastrointestinal symptoms develop in patients in the intervention group, they will undergo tests for the common gastrointestinal diagnoses and positive tests will be treated as per protocol. They will be given symptomatic treatment until their tests are completed. This will not interrupt their cancer treatment. Patients in the treatment as usual group will receive symptomatic treatment. Assessments will coincide with routine oncology review appointments as far as possible. Benefits to Patients and the NHS Acute gastrointestinal symptoms have huge significance in terms of patient health and wellbeing and ability to complete anticancer treatment. They are also linked to long-term gastrointestinal symptoms and the associated reduction in quality of life and social functioning. These simple interventions have the potential to reduce gastrointestinal symptoms and improve quality of life in the short and long-term; improve outcomes of cancer treatment; and reduce healthcare costs. These investigations and treatments are already available in clinical practice and patients could rapidly benefit from the results of this research. The data from this pilot study would inform a larger prospective multicentre randomised controlled trial to confirm the effectiveness of this care bundle in this patient group.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS;ORAL AND GASTROINTESTINAL