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NCT03720158
Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients
NA trial testing Omega 3 Group in Head and Neck Squamous Cell Carcinoma in 9 participants. Terminated before completion.
31 July 2021
Quick facts
| Lead sponsor | Coordinación de Investigación en Salud, Mexico |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 9 |
| Start date | 10 October 2018 |
| Primary completion | 31 July 2021 |
| Estimated completion | 31 July 2021 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Omega 3 Group
- Placebo or Control Group
Conditions studied
- Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
- Quality of Life — all drugs for Quality of Life →
- Radiotherapy; Complications — all drugs for Radiotherapy; Complications →
Sponsor
Coordinación de Investigación en Salud, Mexico — full company profile →
Who can join
Adults 18 to 85, any sex, with Head and Neck Squamous Cell Carcinoma or Quality of Life. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Nutraceuticals and Exercise against Muscle Wasting during Cancer Cachexia.
Aquila G, Re Cecconi AD, Brault JJ, Corli O, et al · · 2020 · cited 32× · PMID 33255345 · DOI 10.3390/cells9122536
Verify or expand the search:
- PubMed search for NCT03720158
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Coordinación de Investigación en Salud, Mexico trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03720158 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Coordinación de Investigación en Salud, Mexico
- Last refreshed: 25 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03720158.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing