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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01596933
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : March 10, 2015
University Hospital, Ghent
Information provided by (Responsible Party):
Dr. Philip Debruyne, General Hospital Groeninge

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.

Condition or disease Intervention/treatment Phase
Cancer Cachexia Head and Neck Cancer Dietary Supplement: BioMega SDA® Dietary Supplement: Sunflower oil high oleic Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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 Start Date : April 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. prevention of therapy-related weight loss [ Time Frame: 7 weeks ]
    difference between body weight at baseline and end of therapy

Secondary Outcome Measures :
  1. determination of beneficial (and possible side) effects of omega-3 FA supplements in general, and specifically on body weight and body composition [ Time Frame: 7 weeks ]
    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

  2. establish feasibility, variability and distribution of BIA, DXA and JAMAR® as objective measurement tools of body composition [ Time Frame: 7 weeks ]
    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

  3. identification of potential clinical risk factors of cachexia [ Time Frame: 7 weeks ]
    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)

  4. evaluation of the use and reliability of different validated nutritional screening tools in this population [ Time Frame: 7 weeks ]
    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

  5. identification and evaluation of potential biomarkers for therapy-induced cachexia [ Time Frame: 7 weeks ]
    identification of serum biomarkers and Single Nucleotide Polymorphisms (SNP)

  6. measurement of difference in quality of life [ Time Frame: 7 weeks ]
    measurement of quality of life (baseline, week 4, end therapy) with EORTC QLQ C30&HN35

  7. dropout and compliance to nutritional supplements [ Time Frame: 7 weeks ]
    number of sachets consumed; omega-3 fatty acid profile as marker for therapy compliance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01596933

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Ghent University Hospital
Ghent, Belgium, 9000
General Hospital Groeninge, Cancer Center
Kortrijk, Belgium, 8500
Sponsors and Collaborators
General Hospital Groeninge
University Hospital, Ghent
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Principal Investigator: Philip R Debruyne, MD PhD General Hospital Groeninge
Principal Investigator: Tom Boterberg, MD PhD University Hospital, Ghent

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Philip Debruyne, Consultant Medical Oncologist, General Hospital Groeninge Identifier: NCT01596933     History of Changes
Other Study ID Numbers: NKP_CA_04
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Keywords provided by Dr. Philip Debruyne, General Hospital Groeninge:
head and neck cancer
omega-3 fatty acid supplementation
echium oil
weight loss
cancer cachexia
body composition
quality of life
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Wasting Syndrome
Neoplasms by Site
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders