NCT01596933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

May 4, 2012

Last Update Submit

March 9, 2015

Conditions

Cancer CachexiaHead and Neck Cancer

Keywords

head and neck canceromega-3 fatty acid supplementationechium oilweight losscancer cachexiabody compositionbiomarkerquality of life

Outcome Measures

Primary Outcomes (1)

  • prevention of therapy-related weight loss

    difference between body weight at baseline and end of therapy

    7 weeks

Secondary Outcomes (7)

  • determination of beneficial (and possible side) effects of omega-3 FA supplements in general, and specifically on body weight and body composition

    7 weeks

  • establish feasibility, variability and distribution of BIA, DXA and JAMAR® as objective measurement tools of body composition

    7 weeks

  • identification of potential clinical risk factors of cachexia

    7 weeks

  • evaluation of the use and reliability of different validated nutritional screening tools in this population

    7 weeks

  • identification and evaluation of potential biomarkers for therapy-induced cachexia

    7 weeks

  • +2 more secondary outcomes

Study Arms (2)

omega-3 fatty acid supplementation

EXPERIMENTAL

omega-3 fatty acid supplementation (echium oil)

Dietary Supplement: BioMega SDA®

standard nutritional support

PLACEBO COMPARATOR

sunflower oil supplementation

Dietary Supplement: Sunflower oil high oleic

Interventions

BioMega SDA®DIETARY_SUPPLEMENT

Echium oil, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy

omega-3 fatty acid supplementation
Sunflower oil high oleicDIETARY_SUPPLEMENT

Sunflower oil high oleic, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy

standard nutritional support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University Hospital

Ghent, 9000, Belgium

Location

General Hospital Groeninge, Cancer Center

Kortrijk, 8500, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 25293388DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsWeight Loss

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philip R Debruyne, MD PhD

    General Hospital Groeninge

    PRINCIPAL INVESTIGATOR

  • Tom Boterberg, MD PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Medical Oncologist

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 11, 2012

Study Start

April 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

BE(2)