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

Head and Neck Cancer Clinical Trial

— NUTRIOM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596933
• Other study ID #: NKP_CA_04
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 4, 2012
• Last updated: March 9, 2015
• Start date: April 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Dietary Supplement:
• BioMega SDA®
Echium oil, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy
• Sunflower oil high oleic
Sunflower oil high oleic, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent
Belgium	General Hospital Groeninge, Cancer Center	Kortrijk

Sponsors (2)

Lead Sponsor	Collaborator
General Hospital Groeninge	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of therapy-related weight loss	difference between body weight at baseline and end of therapy	7 weeks	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	identification and evaluation of potential biomarkers for therapy-induced cachexia	identification of serum biomarkers and Single Nucleotide Polymorphisms (SNP)	7 weeks	No
Secondary	measurement of difference in quality of life	measurement of quality of life (baseline, week 4, end therapy) with EORTC QLQ C30&HN35	7 weeks	No
Secondary	dropout and compliance to nutritional supplements	number of sachets consumed; omega-3 fatty acid profile as marker for therapy compliance	7 weeks	No