Google Maps

NCT07739771

Overview

NCT ID: NCT07739771
Lead Sponsor: Mucosa Innovations, S.L.INDUSTRY
Official Title: Retrospective Evaluation of Severe Oral Mucositis Incidence, Time to Onset and Functional Impact in Quality of Life in Head and Neck Cancer Radiated and Chemo-radiated Patients. Part of the Stop Oral Mucositis Project (STOPOMP)
Brief 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.).
Conditions: Oral Mucositis

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Oct 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 60Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Jorge Manuel Rodríguez-VilaboaContact
jorge.vilaboa@mucosainnovations.com

Similar Studies

Participant Group/Arms

Patients diagnosed with head and neck cancer and treated with Radiotherapy or Chemoradiotherapy

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.