Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.

Sponsor
Mucosa Innovations, S.L.
Study ID
NCT07739771
Status
Not Yet Recruiting

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Conditions

  • Chemotherapeutic Toxicity
  • Mucositis
  • Oral Mucositis
  • Pain
  • Quality of Life
  • Radiation Toxicity
  • Saliva
  • Speech

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.).

Key Dates

First listed
Jul 31, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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. [ Time Frame: Six weeks during radiotherapy. ]

Central Contacts

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