Clinical trial · Interventional
Effect of Omega-3 Supplements on the Prevention of Cachexia in Head and Neck Cancer Treated With Radio(Chemo)Therapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Cachexia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BioMega SDA® | Dietary Supplement | — | UNRESOLVED |
| Sunflower oil high oleic | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- omega-3 fatty acid supplementation
- description
- omega-3 fatty acid supplementation (echium oil)
- interventionNames
- Dietary Supplement: BioMega SDA®
- type
- PLACEBO_COMPARATOR
- label
- standard nutritional support
- description
- sunflower oil supplementation
- interventionNames
- Dietary Supplement: Sunflower oil high oleic
Primary outcomes (1)
- measure
- prevention of therapy-related weight loss
- timeFrame
- 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPottel 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 25293388