PWE-140 A gastrointestinal care bundle versus standard care to reduce the gastrointestinal effects of pelvic chemoradiotherapy: a pilot feasibility randomised controlled trial

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Abstract

Introduction

Following pelvic radiotherapy up to 50% of patients have a permanent change in bowel habit which will affect their quality-of-life. Malnourishment is common prior to treatment and bile acid malabsorption (BAM), lactose intolerance and small bowel bacterial overgrowth (SBBO) can occur during treatment. It was hypothesised that patients who receive a gastrointestinal (GI) care bundle during chemoradiotherapy for pelvic malignancy will have improved GI symptoms and Health-Related Quality-of-Life (HRQL).

Method

This pilot feasibility randomised controlled trial (RCT) included patients with cervical and bladder carcinoma who were undergoing radical chemoradiotherapy. Questionnaire and anthropometric data were collected. The intervention patients received individualised dietary counselling and when they developed lower GI symptoms hydrogen methane breath testing was arranged to detect lactose intolerance and SBBO and a SeHCAT to detect BAM. Treatment was given.

Results

Fifty patients were recruited between December 2012 and January 2015, 24 were randomised to the intervention group and 26 to the control group. All trial patients completed 20 fractions of external beam pelvic radiotherapy. Figure 1 demonstrates the mean bowel scores reported by patients at baseline, 6 weeks, 12 weeks and 52 weeks. As in Table 1 the median bowel score of each group increased at 6 weeks and decreased thereafter. The control group score was higher than the intervention group score at 6 weeks however this study was not powered for hypothesis testing.

Results

Abstract PWE-140 Table 1 The median bowel score of each group at each time point.

Results

The mean HRQL in the control group fell by 0.14 (0.91 at baseline to 0.77 at 52 weeks) compared to 0.06 in the intervention group (0.89 at baseline to 0.83 at 52 weeks) (see figure 2). This relative difference was in part driven by the increased mortality observed in the control arm. All patients developed GI symptoms. It was possible to perform 57/72 (79%) intervention tests.

Conclusion

It was feasible to recruit to and deliver an RCT of GI intervention in patients undergoing pelvic chemoradiotherapy. There was a trend for a lower median bowel score in the intervention group at 6 weeks. This needs testing in a larger RCT.

Disclosure of Interest

None Declared

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