Clinical trial NCT01596933: Effect of Omega-3 Supplements on the Prevention of Cachexia in Head and Neck Cancer Treated With Radio(Chemo)Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cancer Cachexia
Head and Neck Cancer
Keywords: head and neck cancer
omega-3 fatty acid supplementation
echium oil
weight loss
cancer cachexia
body composition
biomarker
quality of life
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2012-05-11
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: prevention of therapy-related weight loss
timeFrame: 7 weeks
Secondary outcomes:
measure: determination of beneficial (and possible side) effects of omega-3 FA supplements in general, and specifically on body weight and body composition
timeFrame: 7 weeks
measure: establish feasibility, variability and distribution of BIA, DXA and JAMAR® as objective measurement tools of body composition
timeFrame: 7 weeks
measure: identification of potential clinical risk factors of cachexia
timeFrame: 7 weeks
measure: evaluation of the use and reliability of different validated nutritional screening tools in this population
timeFrame: 7 weeks
measure: identification and evaluation of potential biomarkers for therapy-induced cachexia
timeFrame: 7 weeks
measure: measurement of difference in quality of life
timeFrame: 7 weeks
measure: dropout and compliance to nutritional supplements
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Kortrijk
country: Belgium
facility: General Hospital Groeninge, Cancer Center
Study officials:
affiliation: General Hospital Groeninge
name: Philip R Debruyne, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Tom Boterberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pottel L, Lycke M, Boterberg T, Pottel H, Goethals L, Duprez F, Maes A, Goemaere S, Rottey S, Foubert I, Debruyne PR. Echium oil is not protective against weight loss in head and neck cancer patients undergoing curative radio(chemo)therapy: a randomised-controlled trial. BMC Complement Altern Med. 2014 Oct 7;14:382. doi: 10.1186/1472-6882-14-382.