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.).
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
Patients with missing or insufficient clinical records required for the study
Patients with concomitant malignancies undergoing active treatment at the same time.
Adults head and neck cancer patients treated in the Radiation Oncology Department, Centro Oncológico Clara Campal, Madrid, Spain, in the period 2019-2023 with RT or CRT, who received the topical oral mucosal supportive care, and had documented oral mucositis assessments available at least throughout the course of RT or CRT.
Cohort
Retrospective
Not listed
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.
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.
Time to onset of severe oral mucositis (grades 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.
Time to onset of severe oral mucositis (grade 3-4), determined through objective clinician assessments that had been performed at weekly intervals during the 6 weeks of radiotherapy, will be collected retrospectively from medical records.
Impact of oral complications experienced by Head & Neck cancer patients during their 6-week radiotherapy (with or without concomitant chemotherapy) and had received the topical mucosa support during 6 weeks.
Data regarding the functional impact on quality of life and feeding impairment due to radiotherapy will be collected retrospectively from medical records, and categorized in a 5-point scale (grade 0-4; 0: no pain, discomfort, or difficulty with eating; 1: mild discomfort, but no difficulty swallowing; 2: moderate pain, but no interference with eating; 3: severe pain with interference in eating solid foods; 4: very severe pain preventing intake of both solid and liquid foods).
Chronic impact of oral complications on quality of life experienced by Head & Neck cancer patients after 6 months of completion of radiotherapy (with or without concomitant chemotherapy) and with topical oral measures support
Data regarding the functional impact on quality of life and feeding impairment due to radiotherapy will be collected retrospectively from medical records, when available. Level of pain, speaking ability, taste perception, salivary function, physical appearance, activity and recreation, swallowing ability, mood, and anxiety will be categorized in a scale ranging from 0 (worst) to 100 (best).
Comparison between clinician's (objective) and patient's (subjective)-reported perception of oral mucositis severity.
WHO scale used by clinician would assess oral mucositis (OM; grade 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, when available data. If available, patient reported outcomes, regarding pain and difficulties in swallowing (grade 0: no pain, discomfort, or difficulty with eating; 1: mild discomfort, but no difficulty swallowing; 2: moderate pain, but no interference with eating; 3: severe pain with interference in eating solid foods; 4: very severe pain preventing intake of both solids and liquids) will be recovered from records along the 6 weeks of RT. Evaluation of possible differences between objective and subjective data will be performed by calculating the agreement proportion and the Spearman´s rho coefficient, provided sufficient data are found.
Adverse events related to the use of the topical measure
Number (percentage) of patients with grade 1-4 NCI-CTCAE adverse events related to the topical measure will be collected from medical records.
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Mucosa Innovations, S.L.
Lead sponsor
Hospital Universitario HM Sanchinarro - Centro Integral Oncológico Clara Campal
Collaborator
Clínica Vilaboa
Collaborator
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