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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Cancer Cachexia
• Intervention / Treatment: Dietary supplement: BioMega SDA®; Dietary supplement: Sunflower oil high oleic

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

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Kortrijk, Belgium, 8500
    • General Hospital Groeninge, Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: omega-3 fatty acid supplementation; omega-3 fatty acid supplementation (echium oil)	Dietary supplement: BioMega SDA®; Echium oil, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy
Placebo Comparator: standard nutritional support; sunflower oil supplementation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevention of therapy-related weight loss	difference between body weight at baseline and end of therapy	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determination of beneficial (and possible side) effects of omega-3 FA supplements in general, and specifically on body weight and body composition	measurement of evolution in body composition (baseline - week 4); measurement of evolution in quality of life (baseline - week 4 - end therapy); measurement of adverse events (CTCAE v4.0)in both groups	7 weeks
establish feasibility, variability and distribution of BIA, DXA and JAMAR® as objective measurement tools of body composition	evolution percentage fat and lean mass (baseline - week 4) as determined by Bio-Elektrical Impedance (BIA) and Dual Energy X-ray Absorptiometry (DXA); evolution grip strength (kg) (baseline - week 4) as determined by JAMAR® hydraulic hand dynamometer	7 weeks
identification of potential clinical risk factors of cachexia	identification of nutritional parameters (obtained from validated nutritional screeners and PG-SGA), demographic, tumour and therapy characteristics, physical, emotional, financial, functional, nutritional and psycho-social characteristics (obtained from EORTC QLQ C30 & HN35), and body composition measurements (% fat, % lean mass, phase angle obtained from BIA, DXA and hand dynamometer)	7 weeks
evaluation of the use and reliability of different validated nutritional screening tools in this population	screening with Short Nutritional Assessment Questionnaire (SNAQ), Mini-Nutritional Assessment short-form (MNA-SF), Malnutrition Universal screening tool (MUST), Nutritional risk screening (NRS 2002), Malnutrition screening tool (MST) and the nutrition risk score (NRS); nutritional assessment with Patient Generated - Subjective Global Assessment (PG-SGA) as gold standard	7 weeks
identification and evaluation of potential biomarkers for therapy-induced cachexia	identification of serum biomarkers and Single Nucleotide Polymorphisms (SNP)	7 weeks
measurement of difference in quality of life	measurement of quality of life (baseline, week 4, end therapy) with EORTC QLQ C30&HN35	7 weeks
dropout and compliance to nutritional supplements	number of sachets consumed; omega-3 fatty acid profile as marker for therapy compliance	7 weeks

Collaborators and Investigators

• Sponsor: General Hospital Groeninge
• Collaborators: University Hospital, Ghent
• Investigators: Principal Investigator: Philip R Debruyne, MD PhD, General Hospital Groeninge; Principal Investigator: Tom Boterberg, MD PhD, University Hospital, Ghent

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 11, 2012

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: quality of life; biomarker; body composition; weight loss; head and neck cancer; cancer cachexia; omega-3 fatty acid supplementation; echium oil
• Additional Relevant MeSH Terms: Metabolic Diseases; Neoplasms; Neoplasms by Site; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Head and Neck Neoplasms; Wasting Syndrome; Cachexia
• Other Study ID Numbers: NKP_CA_04