Upper Gastro-Intestinal Cancer
Conditions
Interventions
INSP, Intensive Nutritional Support Programme
Early dietetic assessment and interventions as deemed neccessary to maintain nutritional requirments
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 - 80 years 2. Confirmed oesophageal or gastric (adenocarcinoma or squamous cell) carcinoma in patients due to undergo neoadjuvant chemotherapy 3. Able to give informed consent and comply with study protocol
Exclusion criteria
Exclusion criteria: 1. Patients with GIST tumours 2. Presence of severe organ specific disease (e.g. heart/respiratory/renal/liver failure) 3. Presence of inherited metabolic disorders 4. Simultaneous participation in another clinical study 5. Patients with suspicion of alcohol/drug abuse 6. Diabetes mellitus or other endocrine disorders (e.g. thyroid disease, Cushing?s syndrome) For second study cohort receiving INSP: 1. Allergy to any constituent of the nutritional supplements 2. Total dysphagia (inability to take oral liquids or solids) 3. Clinical evidence of aspiration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in insulin sensitivity correlated with changes in lean body mass measured at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of chemotherapy toxicity and chemotherapy completion rates 2. Inflammatory cytokine concentrations 3. Insulin sensitivity measured 4. Muscle gene and protein expression 5. Pathological tumour response rates 6. Postoperative infectious and non-infectious complications 7. Respiratory muscle function Measured at the end of the study | — |
Countries
United Kingdom
Outcome results
None listed