Clinical trial · Interventional
Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients
Effect of Enteral Supplementation of Omega 3 Fatty Acids on the Quality of Life and Functionality of Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The activities in the study hospital were seriously impacted by the medical care of COVID patients, affecting the medical management protocol of the study population. This situation does not allow to continue with the recruitment of patients.
Summary
Brief summary (as posted)
Health-related Quality of Life (QoL) is a multidimensional construct that allows us to know the patient's perception of well-being, and how this perception is related to their illness and treatment. In clinical research, especially clinical trials, the QoL measurement has become an important element to evaluate. In patients with Head and Neck Squamous Cell Carcinoma (HNSCC), low QoL is associated with Malnutrition (MN), and Cancer Cachexia (CC) is a principal component in its multifactorial etiology. The exacerbated hypercatabolic state of CC is caused by the increase of pro-inflammatory cytokines, Reactive Oxygen Species (ROS), and other catabolic mediators. The clinical manifestation of CC is a continuous decrease in muscle mass (with or without loss of fat mass), which is not entirely reversible with nutritional support and which leads to the functional deterioration of patients. Due to CC, the patients with HNSCC who receive total enteral nutritional support have difficulties in maintaining an optimal nutritional status, and this situation is more frequent during RadioTherapy (RT). An immune-modulator nutrient, Omega-3 fatty acids (O3) have shown efficacy in improving the nutritional and inflammatory parameters of patients with HNSCC; however, little is known about their impact on patients' QoL and Functionality (Fx). Therefore, this clinical trial is proposed to provide information about the usefulness of O3 for improving the Fx and QoL of patients with HNSCC receiving total enteral nutrition during RT.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Quality of Life | — | UNRESOLVED | — |
| Radiotherapy; Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omega 3 Group | Dietary Supplement | — | UNRESOLVED |
| Placebo or Control Group | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Omega 3 Group
- description
- Five mL of an Omega-3 highly concentrated substance (containing 2.25 g of EPA and 1.08 g of DHA) will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks)
- interventionNames
- Dietary Supplement: Omega 3 Group
- type
- PLACEBO_COMPARATOR
- label
- Placebo or Control Group
- description
- Five mL of pigmented and flavored corn oil will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks)
- interventionNames
- Dietary Supplement: Placebo or Control Group
Primary outcomes (2)
- measure
- Change in Global Health Status/Quality of Life (GHS/QoL) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Head and Neck Squamous Cell Carcinoma (HNSCC) confirmed by histologic * Eligible for receiving total enteral nutrition support through percutaneous endoscopic gastrostomy for the first time * Eligible for receiving RadioTherapy (RT) for the first time Exclusion Criteria: * Allergy to fish * Consumption of anticoagulants * Consumption of any supplement 6 months prior to the experiment * Any contraindication to the performance of the Bioelectrical Impedance Analysis (BIA) (cardiac pacemaker, any metallic prosthesis, inability to stand, severe edema) * Mal-absorption syndrome * Two or more cancer types * Organ dysfunction * Immune diseases * Any hospitalization during the 20 days prior to extraction of the blood sample
References
Publications (10)
- BACKGROUNDPerloy A, Maasland DHE, van den Brandt PA, Kremer B, Schouten LJ. Intake of meat and fish and risk of head-neck cancer subtypes in the Netherlands Cohort Study. Cancer Causes Control. 2017 Jun;28(6):647-656. doi: 10.1007/s10552-017-0892-0. Epub 2017 Apr 5. PMID 28382514
- BACKGROUNDRighini CA, Timi N, Junet P, Bertolo A, Reyt E, Atallah I. Assessment of nutritional status at the time of diagnosis in patients treated for head and neck cancer. Eur Ann Otorhinolaryngol Head Neck Dis. 2013 Feb;130(1):8-14. doi: 10.1016/j.anorl.2012.10.001. Epub 2012 Dec 20. PMID 23266003
- BACKGROUNDRavasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Nutritional deterioration in cancer: the role of disease and diet. Clin Oncol (R Coll Radiol). 2003 Dec;15(8):443-50. doi: 10.1016/s0936-6555(03)00155-9. PMID 14689999
- BACKGROUNDvan Bokhorst-de van der Schueren MA, van Leeuwen PA, Sauerwein HP, Kuik DJ, Snow GB, Quak JJ. Assessment of malnutrition parameters in head and neck cancer and their relation to postoperative complications. Head Neck. 1997 Aug;19(5):419-25. doi: 10.1002/(sici)1097-0347(199708)19:53.0.co;2-2. PMID 9243270
- BACKGROUNDSheth CH, Sharp S, Walters ER. Enteral feeding in head and neck cancer patients at a UK cancer centre. J Hum Nutr Diet. 2013 Oct;26(5):421-8. doi: 10.1111/jhn.12029. Epub 2013 Feb 5. PMID 23379517
- BACKGROUNDFearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4. PMID 21296615
- BACKGROUNDAlshadwi A, Nadershah M, Carlson ER, Young LS, Burke PA, Daley BJ. Nutritional considerations for head and neck cancer patients: a review of the literature. J Oral Maxillofac Surg. 2013 Nov;71(11):1853-60. doi: 10.1016/j.joms.2013.04.028. Epub 2013 Jul 9.