Gastroenterology, Manchester Foundation Trust, Wythenshawe Hospital, Manchester, UK.
Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.
BMJ Open Gastroenterol. 2020 Aug;7(1). doi: 10.1136/bmjgast-2020-000432.
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).
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.
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.
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.
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.
ISRCTN783488.
在英国，每年有 17000 人接受盆腔放疗。十分之八的人在盆腔治疗期间会出现严重的肠道问题，尤其是腹泻、尿急和失禁。有些人无法完成治疗，降低了癌症治愈的机会。在盆腔放疗期间，从未进行过由胃肠病学家主导的调查和管理。在这项研究中，我们旨在评估患者是否能够在放化疗期间成功接受新的胃肠道（GI）护理包（可行性目标），并减轻症状严重程度（临床影响目标）。
这是一项随机对照试验，招募了接受根治性放化疗的宫颈癌和膀胱癌患者。参与者被随机分配到干预组或对照组。收集问卷和人体测量数据。所有干预组患者在整个治疗期间每周接受个体化饮食咨询，如果出现肠道症状，他们将接受快速通道调查，并对任何确定的病理进行治疗：乳糖不耐受、细菌过度生长或胆汁酸吸收不良。
可行性：招募了 50 名参与者，24 名随机分配到干预组，26 名随机分配到对照组。所有患者均完成了 20 次外照射盆腔放疗。共进行了 72 项拟议干预测试中的 57 项（79%），且未对肿瘤学管理造成干扰。
所有参与者在放疗期间均出现胃肠道症状。每组的中位数症状评分在 6 周时从基线开始增加。对照组从 0.156（0.000-0.333）增加到 0.600（0.250-1.286），干预组从 0.00（0.000-0.300）增加到 0.402（0.000-0.667）。
在接受盆腔放化疗的患者中进行随机对照试验和干预措施的招募和实施是可行的。干预组在 6 周时报告的中位肠道评分较低，总体上症状患者较少。
ISRCTN783488。
