Back to resultsEPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -
Primary Purpose
Abdominal Cancer, Radiotherapy; Complications, Weight Loss
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Fish oil
standard care
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Cancer focused on measuring Malnutrition, radiotherapy,, oral nutritional supplements, fish-oil
Eligibility Criteria
Inclusion Criteria:
- referred to radiotherapy for dissminated, abdominal cancer
- > 18 years of age
- able to understand and comply with the intervention
- willingness to participate after oral and written conscent
Exclusion Criteria:
- conditions precluding evaluations of end-points
- dementia
- operations planned in the observation period
Sites / Locations
- Department of Oncology, RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Fish oil
standard care
Arm Description
dietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
The departmental usual procedure with the possibility of requiring of a dietician when needed
Outcomes
Primary Outcome Measures
Change in weight (%)
accumulated weight-loss or gain in per cent of the weight measured between baseline, end of treatment and at follow-up
Secondary Outcome Measures
energy intake (kJ/day) in % of estimated needs
Mean of 3 meausrements in the obeservation period
protein intake (g/kg body weight/day) in % of estimated needs
Mean of 3 meausrements in the obeservation period
Quality of life score (EORTC QLQ-C30 version 3.0) points
difference - before and after intervention
treatment-related side-effects (VAS) scale
questionaire before and after intervention
Full Information
NCT ID
NCT04687124
First Posted
December 23, 2020
Last Updated
December 23, 2020
Sponsor
Jens Rikardt Andersen
Collaborators
Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT04687124
Brief Title
EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -
Official Title
N-3 Fatty Acid EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy - A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rikardt Andersen
Collaborators
Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 2.2 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer, Radiotherapy; Complications, Weight Loss, Energy Supply, Protein Deficiency
Keywords
Malnutrition, radiotherapy,, oral nutritional supplements, fish-oil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomization by sealed envelopes. Stratified for location of cancer
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fish oil
Arm Type
Active Comparator
Arm Description
dietary counselling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
Arm Title
standard care
Arm Type
Placebo Comparator
Arm Description
The departmental usual procedure with the possibility of requiring of a dietician when needed
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Other Intervention Name(s)
Dietary counseling
Intervention Description
Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
No specified intervention
Primary Outcome Measure Information:
Title
Change in weight (%)
Description
accumulated weight-loss or gain in per cent of the weight measured between baseline, end of treatment and at follow-up
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
energy intake (kJ/day) in % of estimated needs
Description
Mean of 3 meausrements in the obeservation period
Time Frame
6 weeks
Title
protein intake (g/kg body weight/day) in % of estimated needs
Description
Mean of 3 meausrements in the obeservation period
Time Frame
6 weeks
Title
Quality of life score (EORTC QLQ-C30 version 3.0) points
Description
difference - before and after intervention
Time Frame
6 weeks
Title
treatment-related side-effects (VAS) scale
Description
questionaire before and after intervention
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
referred to radiotherapy for dissminated, abdominal cancer
> 18 years of age
able to understand and comply with the intervention
willingness to participate after oral and written conscent
Exclusion Criteria:
conditions precluding evaluations of end-points
dementia
operations planned in the observation period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens R Andersen, MD,MPA
Phone
+4523346654
Email
jra@nexs.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Poula Patursson, MSc, RD
Phone
+298 224 112
Email
poulapatursson@gmail.com
Facility Information:
Facility Name
Department of Oncology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen
Phone
+45 454523346654
Email
jra@nexs.ku.dk
First Name & Middle Initial & Last Name & Degree
Grith Møller
Phone
+45
Email
gmp@nexs.ku.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34024504
Citation
Patursson P, Moller G, Muhic A, Andersen JR. N-3 fatty acid EPA supplementation in cancer patients receiving abdominal radiotherapy - A randomised controlled trial. Clin Nutr ESPEN. 2021 Jun;43:130-136. doi: 10.1016/j.clnesp.2021.03.001. Epub 2021 Mar 16.
Results Reference
derived
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