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NCT07739771
Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.
Conditions: Oral Mucositis, Quality of Life, Mucositis, Pain, Speech, Saliva, Radiation Toxicity, Chemotherapeutic Toxicity
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Mucosa Innovations, S.L.
Location: Hospital Universitario HM Sanchinarro - Centro Integral Oncológico Clara Campal Madrid Madrid
Summary
Head and Neck cancer patients receiving radiation therapy (with or without chemotherapy) suffer several oral complications, such as oral mucositis, which impairs quality of life of patients during radiotherapy and in the post-treatment follow-up period. The use of topical agents to protect oral mucosa against radiation-induced toxicity is part of the routine clinical practice. Among these products, the use of mouthwashes and/or gels are extensively used in the Centro Oncológico Clara Campal - Hospital HM Sanchinarro. Once such product is a proprietary formulation based on natural ingredients such as olive oil, betaine, and xylitol (Mucosa Innovations S.L.).
Eligibility Criteria
Inclusion Criteria:
* Adults (≥18 years) diagnosed with head and neck cancer
* Treated with radiotherapy or chemoradiotherapy, with or without surgery and/or immunotherapy, according to tumor type and stage, between 2019 and 2023
* With available medical records documenting clinical assessments of oral mucositis during at least the radiotherapy/CRT treatment period, and that had used the oral mucosa topical measures
Exclusion Criteria:
* Patients with missing or insufficient clinical records required for the study
* Patients with concomitant malignancies undergoing active treatment at the same time.
Source: ClinicalTrials.gov (NCT07739771). StuddyBuddy aggregates publicly available trial information.