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

Last updated: March 9, 2015
Sponsor: General Hospital Groeninge
Overall Status: Completed

Phase

2/3

Condition

Head And Neck Cancer

Human Papilloma Virus (Hpv)

Nasopharyngeal Cancer

Treatment

N/A

Clinical Study ID

NCT01596933
NKP_CA_04
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 parotidgland, or nasal cavity and paranasal sinuses are excluded, as well as cT1 N0 M0tumours of the glottis.

  • Primary cancer or relapse, eligible for primary or adjuvant radiotherapy with orwithout 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

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 rangeas determined by the treating physician)

  • Patients that already underwent a radio(chemo)therapy treatment within the last 6months

  • 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 animplantable cardioverter-defibrillator

  • Patients with a pacemaker will be excluded from BIA-analysis

  • Patients presenting with active intestinal co-morbidity, precluding adequate dietaryintake or interfering with the absorption of the nutritional supplements (eg Crohn'sdisease)

  • 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 4weeks before enrolment

Study Design

Total Participants: 91
Study Start date:
April 01, 2012
Estimated Completion Date:
February 28, 2014

Study 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

Connect with a study center

  • Ghent University Hospital

    Ghent, 9000
    Belgium

    Site Not Available

  • General Hospital Groeninge, Cancer Center

    Kortrijk, 8500
    Belgium

    Site Not Available

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