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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
No specified intervention
Department of Oncology, Rigshospitalet
Copenhagen, Denmark
RECRUITINGChange in weight (%)
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
energy intake (kJ/day) in % of estimated needs
Mean of 3 meausrements in the obeservation period
Time frame: 6 weeks
protein intake (g/kg body weight/day) in % of estimated needs
Mean of 3 meausrements in the obeservation period
Time frame: 6 weeks
Quality of life score (EORTC QLQ-C30 version 3.0) points
difference - before and after intervention
Time frame: 6 weeks
treatment-related side-effects (VAS) scale
questionaire before and after intervention
Time frame: 6 weeks
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