Trial | NCT01596933  Report issue

Title

Effect of Omega-3 Supplements on the Prevention of Cachexia in Head and Neck Cancer Treated With Radio(Chemo)Therapy
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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    91
Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Head and neck (H&N) cancer patients are nutritionally vulnerable since tumour localisation can interfere with food intake, since alcohol and tobacco abuse - two etiological risk factors of H&N cancer - are associated with nutritional deficits, and since the intensive treatment can lead to progressive weight loss. Recently, omega-3 fatty acids have gained interest for their beneficial effects in several diseases. Moreover, nutritional supplementation enriched with omega-3 FA could potentially maintain body weight in cancer patients undergoing intensive treatment.

Aims In this study, the investigators want to evaluate the use of omega-3 FA supplementation as nutritional and the investigators would like to identify potential risk factors, biomarkers and objective measurement tools which can predict therapy-induced cachexia.
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
Study Started
Apr 30
2012
Primary Completion
Feb 28
2014
Study Completion
Feb 28
2014
Last Update
Mar 10
2015
Estimate

Dietary Supplement BioMega SDA®

Echium oil, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy

Dietary Supplement Sunflower oil high oleic

Sunflower oil high oleic, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy

omega-3 fatty acid supplementation Experimental

omega-3 fatty acid supplementation (echium oil)

standard nutritional support Placebo Comparator

sunflower oil supplementation

Criteria 

Inclusion Criteria:

Histologically confirmed squamous cell carcinoma of the head and neck region, generally cancer of the oral cavity, (naso)pharynx and larynx. Cancer of the parotid gland, or nasal cavity and paranasal sinuses are excluded, as well as cT1 N0 M0 tumours of the glottis.
Primary cancer or relapse, eligible for primary or adjuvant radiotherapy with or without systemic treatment, with curative intent
TNM stage I to IVB, without distant metastases
Patients should be older than 18 at the time of enrolment
Patients should be able to adequately communicate in Dutch or French

Exclusion Criteria:

Patients younger than 18 years at the time of recruitment
Pregnant or lactating women
Patients presenting with another non-cured cancer (PSA or CEA not within normal range as determined by the treating physician)
Patients that already underwent a radio(chemo)therapy treatment within the last 6 months
Patients taking oral anticoagulants or LMWH at therapeutic doses
Patients taking anti-epileptics
Patients with an indication of heart failure NYHA 3 or 4, or presence of an implantable cardioverter-defibrillator
Patients with a pacemaker will be excluded from BIA-analysis
Patients presenting with active intestinal co-morbidity, precluding adequate dietary intake or interfering with the absorption of the nutritional supplements (eg Crohn's disease)
Patients with a known eating disorder (eg anorexia nervosa, bulimia nervosa)
Patients with uncontrollable diabetes
HIV-positive patients
Patients with (severe) dementia (DSM-IV criteria)
Patients actively taking fish oil, echium oil or omega-3 FA supplements in the last 4 weeks before enrolment
No Results Posted