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

NCT07739771 | Not Yet Recruiting

• 1 other identifier: XCMOM118retro
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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; Quality of Life; Mucositis; Pain; Speech; Saliva; Radiation Toxicity; Chemotherapeutic Toxicity

Keywords

Oral Mucositis; Cancer Therapy Toxic Effect; Cancer Support; Pain; Ulcers; Treatment Interruptions; Oral Mucosa; Radiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Six weeks during radiotherapy.

Secondary Outcomes (2)

• 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.

  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.

  Six weeks of radiotherapy.

Other Outcomes (3)

• 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

  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.

  Six weeks during radiotherapy.

• Adverse events related to the use of the topical measure

  From the beginning of the 6 week-radiotherapy treatment through 30 days after completion of treatment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Patients with missing or insufficient clinical records required for the study
• Patients with concomitant malignancies undergoing active treatment at the same time.

Sponsors & Collaborators

• Mucosa Innovations, S.L.: lead
• Hospital Universitario HM Sanchinarro - Centro Integral Oncológico Clara Campal: collaborator
• Clínica Vilaboa: collaborator

Study Sites (1)

Hospital Universitario HM Sanchinarro - Centro Integral Oncológico Clara Campal

Madrid, Madrid, 28050, Spain

Location

Related Publications (10)

• Ferlay 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 BACKGROUND

• Sonis 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 BACKGROUND

• Lorini 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 BACKGROUND

• Lalla 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 BACKGROUND

• Sonis 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 BACKGROUND

• Maria 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 BACKGROUND

• Jin 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.

  PMID: 39954082 BACKGROUND

• Anderson C, Saunders D. Oral Mucositis in Head and Neck Cancer Patients. Semin Radiat Oncol. 2025 Apr;35(2):271-277. doi: 10.1016/j.semradonc.2025.02.011.

  PMID: 40090752 BACKGROUND

• Benito-Ramal E, Camacho-Mourelo A, Gonzalez-Navarro B, Lopez JL, Jane-Salas E. Prevalence and risk factors of chronic oral complications in head and neck cancer therapies: A retrospective study. Med Oral Patol Oral Cir Bucal. 2024 Nov 1;29(6):e850-e856. doi: 10.4317/medoral.26823.

  PMID: 39396141 BACKGROUND

• Heinolainen A, Nguyen B, Silen S, Renkonen R, Koskinen M. Survival and data-driven phenotypes in head and neck cancer. Sci Rep. 2025 Feb 18;15(1):5985. doi: 10.1038/s41598-025-89053-6.

  PMID: 39966526 BACKGROUND

MeSH Terms

Conditions

Stomatitis; Mucositis; Pain; Speech; Radiation Injuries; Ulcer

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior; Wounds and Injuries; Pathologic Processes

Study Officials

• Mariola García-Aranda Pez

  Hospital Universitario HM Sanchinarro - Centro Integral Oncológico Clara Campal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Manuel Rodríguez-Vilaboa

CONTACT

+34 629288597; jorge.vilaboa@mucosainnovations.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)