Clinical trial · Observational
Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.
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)
NCT07739771CI-TRIAL-00120156not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Mucositis | — | UNRESOLVED | — |
| Oral Mucositis | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Saliva | — | UNRESOLVED | — |
| Speech | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with head and neck cancer and treated with Radiotherapy or Chemoradiotherapy
- description
- 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 outcomes (1)
- 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.
- timeFrame
- Six weeks during radiotherapy.
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDFerlay J, Colombet M, Soerjomataram I, Parkin DM, Pineros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. Online ahead of print. PMID 33818764
- BACKGROUNDSonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162. PMID 15108222
- BACKGROUNDLorini L, Perri F, Vecchio S, Belgioia L, Vinches M, Brana I, Elad S, Bossi P. Confounding factors in the assessment of oral mucositis in head and neck cancer. Support Care Cancer. 2022 Oct;30(10):8455-8463. doi: 10.1007/s00520-022-07128-w. Epub 2022 May 31. PMID 35639187
- BACKGROUNDLalla RV, Brennan MT, Gordon SM, Sonis ST, Rosenthal DI, Keefe DM. Oral Mucositis Due to High-Dose Chemotherapy and/or Head and Neck Radiation Therapy. J Natl Cancer Inst Monogr. 2019 Aug 1;2019(53):lgz011. doi: 10.1093/jncimonographs/lgz011. PMID 31425601
- BACKGROUNDSonis ST. Oral mucositis in head and neck cancer: risk, biology, and management. Am Soc Clin Oncol Educ Book. 2013. doi: 10.14694/EdBook_AM.2013.33.e236. PMID 23714511
- BACKGROUNDMaria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017. PMID 28589080
- BACKGROUNDJin Y, Wang J, Wang Y. Unraveling the complexity of radiotherapy- and chemotherapy-induced oral mucositis: insights into pathogenesis and intervention strategies. Support Care Cancer. 2025 Feb 15;33(3):195. doi: 10.1007/s00520-025-09239-6.