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    Randomised clinical trial of a gastrointestinal care bundle to reduce symptoms in patients with pelvic cancer undergoing chemoradiotherapy

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    Authors
    White, K. L.
    Henson, C. C.
    Hann, M.
    Eden, M.
    Burden, S. T.
    Lal, S.
    Davidson, Susan E
    McLaughlin, J. T.
    Affiliation
    Gastroenterology, Manchester Foundation Trust, Wythenshawe Hospital, Manchester, UK.
    Issue Date
    2020
    
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    Abstract
    Objective: Pelvic radiotherapy is used to treat 17 000 people in the UK each year. Eight in 10 develop difficult bowel problems during pelvic treatment, especially diarrhoea, urgency and incontinence. Some cannot complete treatment, reducing the chance of cancer cure. Undertaking gastroenterologist-led investigation and management during pelvic radiotherapy has never been evaluated. In this study, we aimed to assess whether patients could successfully receive a novel gastrointestinal (GI) care bundle during chemoradiotherapy (feasibility aim) and would experience reduced symptom severity (clinical impact aim). Design: This randomised controlled trial recruited patients with cervical and bladder cancers undergoing radical chemoradiotherapy. Participants were randomised to intervention or control groups. Questionnaire and anthropometric data were collected. All intervention group patients received individualised dietary counselling weekly throughout treatment, and if bowel symptoms developed they were offered rapid-access investigation and treatment for any identified pathology: lactose intolerance, bacterial overgrowth or bile acid malabsorption. Results: Feasibility: 50 participants were recruited, 24 were randomised to the intervention group and 26 to the control group. All completed 20 fractions of external beam pelvic radiotherapy. It was possible to perform 57/72 (79%) of proposed intervention tests with no disruption of oncological management. Clinical impact: All participants developed GI symptoms during radiotherapy. The median symptom score for each group increased from baseline at 6 weeks. This was from 0.156 (0.000-0.333) to 0.600 (0.250-1.286) in the control group, and from 0.00 (0.000-0.300) to 0.402 (0.000-0.667) in the intervention group. Conclusion: It was feasible to recruit to and deliver a randomised controlled trial of interventions in patients undergoing pelvic chemoradiotherapy. Lower median bowel scores were reported in the intervention group at 6 weeks, with fewer patients experiencing symptoms overall. Trial registration number: ISRCTN783488. Keywords: cancer; clinical trials; radiation enteritis; radiotherapy.
    Citation
    White KL, Henson CC, Hann M, Eden M, Burden ST, Lal S, et al. Randomised clinical trial of a gastrointestinal care bundle to reduce symptoms in patients with pelvic cancer undergoing chemoradiotherapy. BMJ Open Gastroenterology. 2020;7(1):e000432.
    Journal
    BMJ Open Gastroenterology
    URI
    http://hdl.handle.net/10541/623282
    DOI
    10.1136/bmjgast-2020-000432
    PubMed ID
    32771983
    Additional Links
    https://dx.doi.org/10.1136/bmjgast-2020-000432
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1136/bmjgast-2020-000432
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