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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04687124
Other study ID # H-D-2007-0134
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 15, 2018
Est. completion date February 2021

Study information

Verified date December 2020
Source University of Copenhagen
Contact Jens R Andersen, MD,MPA
Phone +4523346654
Email jra@nexs.ku.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date February 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Fish oil
Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
Other:
standard care
No specified intervention

Locations

Country Name City State
Denmark Department of Oncology, Rigshospitalet Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Jens Rikardt Andersen Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in weight (%) accumulated weight-loss or gain in per cent of the weight measured between baseline, end of treatment and at follow-up 6 weeks
Secondary energy intake (kJ/day) in % of estimated needs Mean of 3 meausrements in the obeservation period 6 weeks
Secondary protein intake (g/kg body weight/day) in % of estimated needs Mean of 3 meausrements in the obeservation period 6 weeks
Secondary Quality of life score (EORTC QLQ-C30 version 3.0) points difference - before and after intervention 6 weeks
Secondary treatment-related side-effects (VAS) scale questionaire before and after intervention 6 weeks
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