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.
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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
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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
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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
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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.
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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
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