An observational study in Oral Mucositis, Quality of Life and Mucositis, sponsored by Mucosa Innovations, S.L.. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Mucosa Innovations, S.L. · Observational
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.).
Radiotherapy, with or without chemotherapy, is the standard treatment for patients diagnosed with head and neck cancer, a disease that accounts for approximately 5% of all cancers diagnosed worldwide and whose incidence is estimated to increase by approximately 64% by 2050. Head and neck cancer is the sixth most common cancer worldwide, with a 5-year survival rate of 50-60%.
Treatment with radiotherapy (RT) or chemoradiotherapy (CRT) in patients with head and neck cancer is frequently associated with the development of acute complications affecting the oropharyngeal cavity, such as oral mucositis, a common toxicity that may lead to multiple functional consequences during oncological treatment. Medium- to long-term complications, also referred to as chronic complications, significantly affect quality of life and include dysphagia, odynophagia, xerostomia, loss of taste, mucosal atrophy, and fibrosis, among others.
Oral mucositis, the most common oral complication during treatment, affects 90-100% of patients with head and neck cancer treated with radiation therapy. The incidence of severe oral mucositis (WHO grade 3-4) in patients with head and neck cancer receiving chemoradiotherapy is approximately 65-70%, whereas in those receiving radiotherapy alone, the incidence is 57%.
In some patients, mucositis may cause significant oral pain that impacts food and fluid intake, leading to serious difficulties and limitations in nutrition and a substantial deterioration in quality of life. Furthermore, in severe cases, oral mucositis may result in additional complications such as infections, treatment interruptions and delays, and even treatment discontinuation.
The literature indicates that severe forms of oral mucositis are responsible for 20-30% of early interruptions in oncological treatment, potentially compromising treatment success and patient survival.
Routine clinical practice for patients with head and neck cancer includes, in addition to RT/CRT, the use of topical agents intended to protect the oral mucosa against treatment-induced toxicity. Standard clinical practice in these patients may include, among other supportive measures, the use of mouthwash and/or topical gel based on natural ingredients olive oil, betaine, and xylitol, an intellectually protected composition (Mucosa Innovations S.L.).
Retrospective studies provide valuable complementary evidence to clinical trials by capturing the effectiveness and safety of treatments in routine clinical practice settings. In this context, the present protocol aims to retrospectively identify patients with head and neck cancer who were exposed, as part of routine daily practice, to the oral mucosal supportive measures described above, while describing the sociodemographic characteristics and clinical variables collected during routine clinical care. The study aims to contribute to a better understanding of, and to help address existing gaps in the management of patients with head and neck cancer.
This protocol describes a retrospective observational study designed to collect data on oral complications and their functional impact in quality of life in patients treated in the Oncological Radiotherapy Unit according to the implemented standard of care for oncological treatment (RT/CRT) and oral mucosal management through topical approachs such as the previously described gel and mouthwash.
The aim of this trial is to identify the presence of oral complications, such as oral mucositis, its severity, time to onset and functional impact on quality of life during treatment in patients with head and neck cancer treated with radiotherapy or chemoradiotherapy, as well as during the post-treatment follow-up period, in patients who received topical oral mucosal care.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 20 observational studies indexed under Stomatitis.
Browse Stomatitis studies →Mucosa Innovations, S.L. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Retrospective cohort of adult patients diagnosed with and treated for head and neck cancer under routine clinical practice at the Radiation Oncology Department-Centro Oncológico Clara Campal between 2019-2023 Data will be retrospectively recovered from registries from patients who had been treated with radiotherapy (with or without concomitant chemotherapy), and topical oral mucosal measures, and for whom oral mucositis assessments are available throughout at least the RT/CRT treatment period.
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 frame: Six weeks during radiotherapy.
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.
Time frame: Six weeks during radiotherapy.
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).
Time frame: Six weeks of radiotherapy.
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).
Time frame: Post-treatment follow-up period starting at least 6 months after the end of radiotherapy.
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.
Time frame: Six weeks during radiotherapy.
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.
Time frame: From the beginning of the 6 week-radiotherapy treatment through 30 days after completion of treatment
Plan to share: No
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Mucosa Innovations, S.L.