The Royal Marsden Dietetic Research at RMH: Nutritional Screening Tools Intervention during pelvic RT Small Intestinal Bacterial Overgrowth (SIBO) Linda J Wedlake / Eva Grace Research Dietitians The Royal Marsden NHS Foundation Trust The Royal Marsden Validation of Nutrition Screening Tools Clare Shaw PhD RD Catherine Fleuret BSc RD Clare Shaw PhD RD Gayle Loader BSc RD Catherine Jennifer Fleuret BSc RD Pickard BSc RD Gayle Loader BSc RD Jennifer Pickard BSc RD The Royal Marsden Validation of nutrition screening tools – Important that we are able to make a quick judgment on a patient’s nutrition when they are admitted to hospital – A number of screening tools available but they are not specific for cancer patients – Screening in the clinical setting allows – Collection of baseline data to allow ongoing monitoring – Identification of patients who require extra advice and support – Planning for patients who require more intensive nutritional support – The Royal Marsden currently uses its own screening tool but this study aims to validate a shorter/ easier version of the screening tool and test another published tool that is used in oncology outpatients – Whichever screening tool is shown to be the best will be implemented in clinical practice The Royal Marsden The Study – A thorough interview and physical examination of the patient is regarded as the ‘gold standard’ for assessing the nutritional status of the patient. – Called the Patient Generated Subjective Global Assessment (PG-SGA) – It is based on – Weight and weight changes – Changes in food intake – Symptoms that affect food intake – Functional status (activities able to perform) – Clinical status (including whether the patient has infection) – Physical examination looking at muscle and fat stores – This is undertaken by one dietitian on all 128 patients – 2 Clinical dietitians complete the screening tools on the patients – The results of these two assessments will be compared at the end of the study to determine which screening tool should be used. The Royal Marsden Benefits to patients and staff – Focused on an important aspect of patient care – Directly relevant to our clinical practice – The results will be implemented at the end of the study – Opportunity for more junior staff to gain experience in undertaking clinical research The Royal Marsden Nutritional Interventions during Pelvic Radiotherapy Clare Shaw PhD RD Catherine Fleuret BSc RD Wedlake RD MSc Gayle Loader BSc RD Shaw RD PhD Jennifer Pickard BSc RD Linda Clare Jervoise Andreyev MA PhD FRCP The Royal Marsden Numbers Radiotherapy used for 50% of new cancers >90% patients with new onset acute symptoms Change in bowel habit (90%) Loose stool (80%) Urgency (39%) Faecal incontinence (37%) 50% with troublesome late symptoms > 300,000/annum treated with pelvic RT Survivorship issues of increasing importance Khalid et al 2006 IJROBP 64:1432-41 The Royal Marsden Radiotherapy delivery The Royal Marsden Mucosal damage Normal rectal epithelium pre-RT: Regular glands & mucin content Gland distortion & cryptitis: During-RT (18 Gray) Hovdenak et al 2000 IJROBP 48:1111-7 The Royal Marsden Nutritional Issues RT-induced inflammation leading to: Lactose intolerance Bile Salt malabsorption Fat malabsorption Bacterial overgrowth Motility disruption Normal secretions become damaging Consequential late effects The Royal Marsden IMPORTANCE of intervention: Radiotherapy dose does not account for all toxicity Non-treatment related factors can be manipulated for longer-term benefit Moderate but sustained toxicity is as damaging (or more so) as single episodes The Royal Marsden How late and how severe? The Royal Marsden Nutritional strategies McGough 2004 BJC; 90:2278-87, Wedlake et al 2012 (Submitted) The Royal Marsden Nutritional strategies n (patients): 839 316 275 287 868 5 4 4 5 5 3 3 3 0 5 Compliance Intervention TOTAL: 2585 n (studies): TOTAL: 23 n (positive): TOTAL: 14 PROBLEMS: Substrate No evidence Methodology 61% of studies returned a positive result BUT meta-analysis not possible The Royal Marsden Fibre: rationale ≥10 mono-meric units Not hydrolysed in SI Fermentable and inert Dietary or supplemental Stool bulking Water absorption SCFA production Interaction via microbiota The Royal Marsden Fibre: Evidence & issues – – – – – – – – – Total: 4 studies (n=275) Supplement (n=2), diet (n=2) RCT (n=2) largest (n=60) Favourable outcomes (n=3): Reduced severity diarrhoea, and improved IBDQ score LOW fibre favourable (n=1) HIGH fibre favourable (n=2) Fibre intervention suspended (n=1) due to lack of efficacy Positive impact of (mixed) dietary intervention noted – Supplement, dietary and mixed interventions used – Soluble and insoluble fractions have different effects – Efficacy of fibre on toxicity not primary outcome (n=2) – Non-validated diarrhoea scoring (n=1) – Objective measures (n=1) The Royal Marsden Fibre Study Design A randomised controlled trial in patients due to receive radical radiotherapy for pelvic cancers (Gy Gi) 3-arm design: requires 177 patients Group 1 Low fibre diet (≤10g / day) Group 2 High fibre diet (18-22g / day) Group3 No intervention (normal diet) Study numbers: 52 per Group = 156 Plus 7/group contingency = 177 The Royal Marsden Small Intestinal Bacterial Overgrowth (SIBO) during Cancer Therapy Clare Shaw PhD RD Fleuret BSc RD Eva GraceCatherine RD BSc Gayle Loader BSc RD Clare Shaw RD PhD Jennifer Pickard BSc RD Jervoise Andreyev MA PhD FRCP William Allum FRCS Unell Riley PhD Lillian Li BSc The Royal Marsden Background / Rationale 1. SIBO is prevalent in patients during and after treatment for oesophago-gastric cancers and where it exists it has a significant impact on their GI function and nutritional status. 2. A simple, accurate, specific and sensitive test for diagnosing SIBO would represent a major stride forward for patients and clinicians. 19 The Royal Marsden SIBO Clinical Presentation: • Diarrhoea, steatorrhoea, nausea, vomiting, abdominal pain, bloating, constipation • Nutrient malabsorption (Fe, B12 ) • Bile salt malabsorption • Diagnosis: duodenal aspirate + culture or breath tests • Positive glucose breath test in 25% of patients Predisposing Factors: • Previous surgery, dysmotility, gut wall injury, anatomical, neuromuscular Treatment: • Antibiotics 20 The Royal Marsden SIBO I: Design, Aims Design: • Prospective, observational • Newly diagnosed oesophago-gastric cancer patients • Baseline, 4 follow-ups over 12 months • n = 261 Aims: Primary Outcome: Prevalence of SIBO Secondary Outcomes: • Prevalence of malnutrition (PGSGA) • Nutrient + food group intake (FFQ) • Prevalence + severity of GI symptoms (GSRS) • Compare outcomes in those who do and don’t develop SIBO 21 The Royal Marsden SIBO I: Progress to Date Ethical and RMH R & D approval: Oct - Nov 2011 Recruitment start date: Nov 2011 Recruitment to date: n = 26 Target Completion Date: Jan 2014 22 The Royal Marsden SIBO II Study: Design, Aims Design: Prospective, observational Patients suspected of having SIBO Baseline and 1 follow-up at 3 - 4 months n = 195 Primary Aim: To develop a new method for SIBO diagnosis in association with established tests and 1H-NMR technology. 23 The Royal Marsden SIBO II Study: Progress to Date Ethical and RMH R&D approval: Dec - Feb 2012 Recruitment start date: March 2012 Recruitment to date: n = 47 Target Completion Date: Jan 2014 24
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