Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.
Oral MucositisQuality of LifeMucositisPainSpeechSalivaRadiation ToxicityChemotherapeutic Toxicity
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of severe oral mucositis (grade 3-4) in Head & Neck cancer patients who had been treated with radiotherapy (with or without concomitant chemotherapy) and had received the topical mucosa support during 6 weeks. — Six weeks during radiotherapy. Oral mucositis severity data will be collected retrospectively from medical records in which assessments had been performed by the clinician using the WHO scale (grade 0-4; 0: no remarkable findings, 1: erythema and discomfort, without ulcers, 2: erythema and ulcers, but able to tolerate solid food; 3: ulcers, only able to tolerate liquids; 4: unable to tolerate solids or liquids), at weekly intervals during the 6 weeks of treatment.
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario HM Sanchinarro - Centro Integral Oncológico Clara Campal
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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