Body composition, nutrition & outcomes after neoadjuvant chemotherapy

ISRCTN	ISRCTN15674981
DOI	https://doi.org/10.1186/ISRCTN15674981
Secondary identifying numbers	11565

Submission date: 13/03/2012
Registration date: 13/03/2012
Last edited: 20/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-body-changes-during-chemotherapy-and-nutitional-support-for-people-having-treatment-for-stomach-or-oesophageal-cancer

Contact information

Prof Dileep Lobo
Scientific

University of Nottingham
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Phone	+44 115 823 1155
Email	dileep.lobo@nottingham.ac.uk

Study information

Study design	Non-randomised interventional prevention trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effects of an intensive nutritional support programme on body composition, insulin resistance and outcomes during neoadjuvant chemotherapy for oesophagogastric cancer: A before and after pilot study
Study objectives	Oesophageal and gastric cancer together represent the third most common cause of cancer death in the UK. The prognosis is often poor with overall UK 5-year survival rates being approximately 8% and 14% for oesophageal and stomach cancer, respectively. The majority of patients present with advanced disease and many have significant co-morbidities. Patients presenting with locally advanced resectable disease typically undergo 3 cycles of neoadjuvant chemotherapy (NAC) over 2 months followed by surgery, a regimen based on the MAGIC trial, which leads to down-staging of tumours and significantly improves progression-free and overall survival. Whilst nutritional depletion is commonly encountered in patients with oesophagogastric (OG) cancers, most patients undergoing NAC do not receive nutritional support. Furthermore, there are limited data on preoperative nutritional support of patients with OG cancer undergoing NAC, the majority of previous studies utilising parenteral nutrition, which is expensive, invasive and carries risks of infectious morbidity. This pilot study aims to investigate: 1.The development of sarcopenia (loss of FFM) in patients with OG cancer undergoing NAC increases chemotherapy-related toxicity, limits treatment and influences oncological outcome 2. Loss of FFM (muscle) leads to an increase in insulin resistance and associated post operative complications 3. An intensive nutritional support programme (INSP) during NAC can reverse the loss of FFM and the development of insulin resistance and whether this affects clinical outcomes
Ethics approval(s)	ref: 11/EM/0419
Health condition(s) or problem(s) studied	Upper Gastro-Intestinal Cancer; Oesophagus, Stomach
Intervention	INSP, Intensive Nutritional Support Programme Early dietetic assessment and interventions as deemed neccessary to maintain nutritional requirments
Intervention type	Other
Primary outcome measure	Changes in insulin sensitivity correlated with changes in lean body mass measured at the end of study
Secondary outcome measures	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
Overall study start date	20/02/2012
Completion date	20/02/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	Planned Sample Size: 20; UK Sample Size: 20
Key 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
Key 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, Cushings 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
Date of first enrolment	20/02/2012
Date of final enrolment	20/02/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Nottingham

Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom

Phone	+44 115 951 5151
Email	dileep.lobo@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Charity

Core - The Digestive Disorders Foundation (UK)

No information available

Nottingham University Hospitals Charity (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/04/2016: No publications found, verifying study status with principal investigator.