Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04687124
Status:
UNKNOWN
Last Update Posted:
2020-12-29
First Post:
2020-12-23
Brief Title:
EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -
Sponsor:
Jens Rikardt Andersen
Organization:
University of Copenhagen
Study Overview
Official Title:
N-3 Fatty Acid EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy - A Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal GI area and can lead to negative outcomes N-3 fatty acids from fish especially eicosapentaenoic acid EPA may possess anticachectic properties The aim of this study is to investigate the effect of two nutritional interventions dietary counselling and an oral nutritional supplement ONS containing 22 g of the n-3 fatty acid EPA Forticare or standard care including dietary counselling and protein supplementation when needed
Detailed Description:
Methods Outpatients commencing radiotherapy to the GI area due to dissiminated cancer are randomized to receive dietary counselling and daily fish-oil supplementation over a 5-7 week period or standard care Outcome parameters are measured at baseline onset of radiotherapy week 5 and 12 weeks after commencing radiotherapy with one additional measurement of body weight at week 2 Quality of life QoL is measured using the EORTC QLQ-C30 questionnaire Radiotherapy-related side effects are assessed using a questionnaire developed specifically for this study Data from a historical control group collected in a previous observational study is included in this study to compare incidence of weight loss
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None