Condition category
Cancer
Date applied
13/03/2012
Date assigned
13/03/2012
Last edited
20/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Dileep Lobo

ORCID ID

Contact details

University of Nottingham
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 115 823 1155
dileep.lobo@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11565

Study information

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

Acronym

Study hypothesis

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

ref: 11/EM/0419

Study design

Non-randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

20/02/2012

Overall trial end date

20/02/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant 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

Recruitment start date

20/02/2012

Recruitment end date

20/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
+44 115 951 5151
dileep.lobo@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Charity

Funder name

Core - The Digestive Disorders Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nottingham University Hospitals Charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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