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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cancer Cachexia, Head and Neck Cancer

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

prevention of therapy-related weight loss

Outcome Description:

difference between body weight at baseline and end of therapy

Outcome Time Frame:

7 weeks

Safety Issue:

No

Principal Investigator

Philip R Debruyne, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

General Hospital Groeninge

Authority:

Belgium: Ethics Committee

Study ID:

NKP_CA_04

NCT ID:

NCT01596933

Start Date:

April 2012

Completion Date:

April 2014

Related Keywords:

  • Cancer Cachexia
  • Head and Neck Cancer
  • head and neck cancer
  • omega-3 fatty acid supplementation
  • echium oil
  • weight loss
  • cancer cachexia
  • body composition
  • biomarker
  • quality of life
  • Cachexia
  • Head and Neck Neoplasms

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