Multi-centric, Placebo-controlled Trial of Omega-3 Fatty Acid Supplementation in Weight Maintenance and Preservation of Lean Body Mass, in (Pre)Cachectic Head and Neck Cancer Patients, Undergoing Curative Radio(Chemo)Therapy
Design A prospective, placebo-controlled trial. H&N cancer patients eligible for curative
treatment will be randomised to receive standard nutritional support with placebo (15ml/day
Sunflower oil, control group) or nutritional support with omega-3 FA supplementation
(15ml/day Echium oil, experimental group) during radio(chemo)therapy. All patients will
undergo a nutritional screening (Patient-Generated Subjective Global Assessment), a quality
of life evaluation (EORTC QLQ C30 & HN35) and will be asked to keep a 3-day food diary at
the start of their therapy, and again during the 4th week and the end of therapy. Body
composition and grip strength will be measured with bio-electrical impedance (BIA) analysis,
Dual X-ray absorptiometry (DXA) and the JAMAR® hydraulic hand dynamometer once at baseline,
and again in the 4th week of therapy. Blood samples are collected at baseline, and in the
4th week of therapy to (1) verify compliance rate by measuring fatty acid concentration, (2)
verify the presence of potential biomarkers that can predict cachexia and (3) to detect the
presence of SNPs associated with severe acute dysphagia. Demographic data, tumour
characteristics and therapy-related toxicity will also be collected.
Population Newly diagnosed non-metastatic (stage I-IVB) head and neck cancer patients (≥18
or older) eligible for curative primary or adjuvant radiotherapy with or without systemic
therapy
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
prevention of therapy-related weight loss
difference between body weight at baseline and end of therapy
7 weeks
No
Philip R Debruyne, MD PhD
Principal Investigator
General Hospital Groeninge
Belgium: Ethics Committee
NKP_CA_04
NCT01596933
April 2012
April 2014
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