Abdominal Cancer, Energy Supply, Protein Deficiency, Radiotherapy; Complications, Weight Loss
Conditions
Keywords
Malnutrition, radiotherapy,, oral nutritional supplements, fish-oil
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.
Interventions
DIETARY_SUPPLEMENTFish oil
Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
OTHERstandard care
No specified intervention
Sponsors
Department of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
Jens Rikardt Andersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization by sealed envelopes. Stratified for location of cancer
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight (%) | 6 weeks | accumulated weight-loss or gain in per cent of the weight measured between baseline, end of treatment and at follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| energy intake (kJ/day) in % of estimated needs | 6 weeks | Mean of 3 meausrements in the obeservation period |
| protein intake (g/kg body weight/day) in % of estimated needs | 6 weeks | Mean of 3 meausrements in the obeservation period |
| Quality of life score (EORTC QLQ-C30 version 3.0) points | 6 weeks | difference - before and after intervention |
| treatment-related side-effects (VAS) scale | 6 weeks | questionaire before and after intervention |
Countries
Denmark
Contacts
Primary ContactJens R Andersen, MD,MPA
Backup ContactPoula Patursson, MSc, RD
Outcome results
None listed