Pre-surgery dietetic services in resectable pancreatic cancer - V1
Research type
Research Study
Full title
In comparison to usual care alone, does an adjunctive pre-surgery dietetic service improve the post-surgical nutritional outcomes for patients with pancreatic cancer? A pilot study\n
IRAS ID
218349
Contact name
Martin Cartwright
Contact email
Sponsor organisation
City, University of London
Duration of Study in the UK
0 years, 7 months, days
Research summary
This pilot trial investigates the effect of an adjunctive pre-surgery dietetic service on the post-surgical nutritional outcomes, compared to usual care in a sample of patients with resectable pancreatic cancer. ‘Usual care’ refers to surgeon-led outpatient pre-surgical assessments with no specialist nutrition management involved.\n\nThis research is important because around 80% of pancreatic cancer surgical patients are malnourished at diagnosis, due to complex (but modifiable) cancer-related nutritional problems. Poorer nutritional status before surgery is associated with increased post-operative morbidity and mortality. Dietitians are trained to manage malnutrition but evidence on the impact of pre-surgery dietary advice services for this patient group is sparse and to date there have been no randomised trials. \n\nThis study is a pilot RCT with two arms, control (usual care) vs intervention (usual care + pre-surgery dietetic adjunct) at Hammersmith Hospital. The complete intervention consists of 3 dietary advice sessions (1 x face to face (45minutes) and 2x telephone sessions (30minutes). The intervention is delivered between 8 and 2 weeks prior to surgery. \n\nContent of the dietary advice intervention:\n\nStep 1: \nA comprehensive dietary assessment. The information below is collected from a combination between clinical records and directly from the participant:\n1. Anthropometric (body) measurements.(e.g. weight and height, calf and arm ciscumference )\n2. Biochemistry values.\n3. Past and current medical history\n4. Patient reported symptoms due to the cancer.\n5. Dietary consumption assessment and calculated nutritional daily requirements.\n6. Social history\n\nStep 2: \nThe dietitian makes a nutritional diagnosis and provides a set of recommendations to manage the nutritional status of the patient. These recommendations are communicated clearly (verbally and in writing) to the study participant, and in writing to their GP and surgical medical team.\n\nData collection occurs at 3 time-points:\nTwo are prior to surgery:\n- Before assignment to a trial arm\n- About one week before surgery (after receipt of the complete intervention)\nAnd one is after surgery:\n- About 2 weeks after surgery\n
REC name
London - Bloomsbury Research Ethics Committee
REC reference
17/LO/0746
Date of REC Opinion
5 Jul 2017
REC opinion
Further Information Favourable Opinion