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Cancer CachexiaPhase 2/3NUTRIOMNCT01596933

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

A Phase 2/3 study testing BioMega SDA® and Sunflower oil high oleic in people with Cancer Cachexia and Head and Neck Cancer, run by General Hospital Groeninge at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Cachexia, Head and Neck Cancer
What is being tested?
BioMega SDA® and Sunflower oil high oleic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
2 sitesBelgium
Study dates
Apr 2012to Feb 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • Ghent University Hospital

    Ghent, 9000

  • General Hospital Groeninge, Cancer Center

    Kortrijk, 8500

Other trials in Belgium

About this study

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

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.

Read the 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

Being tested
BioMega SDA®, Sunflower oil high oleic
Keywords
head and neck cancer, omega-3 fatty acid supplementation, echium oil, weight loss, cancer cachexia, body composition, biomarker, quality of life
Medical subject headings
Head and Neck Neoplasms, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioMega SDA®Dietary supplement

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

  • 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

Study groups in NCT01596933
Study groupRoleWhat they receive
omega-3 fatty acid supplementationExperimentalomega-3 fatty acid supplementation (echium oil)
Receives: Dietary Supplement: BioMega SDA®
standard nutritional supportPlacebo comparatorsunflower oil supplementation
Receives: Dietary Supplement: Sunflower oil high oleic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prevention of therapy-related weight loss

    difference between body weight at baseline and end of therapy

    Measured: 7 weeks

Secondary outcomes (7)

  1. 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

    Measured: 7 weeks

  2. 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

    Measured: 7 weeks

  3. 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)

    Measured: 7 weeks

  4. 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

    Measured: 7 weeks

  5. identification and evaluation of potential biomarkers for therapy-induced cachexia

    identification of serum biomarkers and Single Nucleotide Polymorphisms (SNP)

    Measured: 7 weeks

  6. measurement of difference in quality of life

    measurement of quality of life (baseline, week 4, end therapy) with EORTC QLQ C30\&HN35

    Measured: 7 weeks

  7. dropout and compliance to nutritional supplements

    number of sachets consumed; omega-3 fatty acid profile as marker for therapy compliance

    Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01596933
Sponsor's protocol ID
NKP_CA_04
Acronym
NUTRIOM
Status last verified
Mar 2015
First submitted
4 May 2012
Last updated
10 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25293388

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BioMega SDA® and Sunflower oil high oleic in people with Cancer Cachexia and Head and Neck Cancer, run by General Hospital Groeninge at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prevention of therapy-related weight loss (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01596933, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.

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