Exploring potential benefit of earlier nutritional interventions in adults with upper gastrointestinal cancer: a randomised trial

Not Applicable

• Conditions: Oesophageal cancer; Cancer - Oesophageal (gullet); Cancer - Stomach; Stomach cancer

• Registration Number: ACTRN12611000005954
• Lead Sponsor: Mary Anne Silvers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion:
i) All patients with a histological proven diagnosis of cancer of the oesophagus or stomach who are to undergo surgery and/or chemotherapy at Southern Health
ii) Provision of consent

Exclusion Criteria

Exclusion:
i) Under 18 years of age
ii) Patients diagnosed with recurrent disease
iii) Patients with physical, cognitive, language or emotional problems would prevent participation as determined by treating consultant
iv) Patients who were to undergo surgery and/or chemotherapy at another health service

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EQ-5D (European Quality of Life index) with visual analogue scale[Baseline (study entry) taken at initial diagnosis.<br>At the time of commencement of pre-operative chemotherapy (if chemotherapy is provided)<br>At the time of surgery (if suregery is provided)<br>26 week post-initial assessment]

Secondary Outcome Measures

Name	Time	Method
European Organisation for Research and Treatment in Cancer - C30 instrument[Baseline (study entry) taken at initial diagnosis.<br>At the time of commencement of pre-operative chemotherapy (if chemotherapy is provided)<br>At the time of surgery (if suregery is provided)<br>26 week post-initial assessment];Participant self-reported weight in kilograms[Baseline (study entry) taken at initial diagnosis.<br>At the time of commencement of pre-operative chemotherapy (if chemotherapy is provided)<br>At the time of surgery (if suregery is provided)<br>26 week post-initial assessment];Patient Generated Subjective Global Assessment[Baseline (study entry) taken at initial diagnosis.<br>At the time of commencement of pre-operative chemotherapy (if chemotherapy is provided)<br>At the time of surgery (if suregery is provided)<br>26 week post-initial assessment]