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NCT05614843
Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy
Conditions: Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 30
Sponsor: Universidad de Granada
Location: Spain
Summary
Patients with head and neck cancer post-radiotherapy may improve their perceived and amount of saliva after a 3-month Photobiomodulation (PBM) therapy focuses on three main salivary glands (parotid, submandibular and sublingual glands).
Eligibility Criteria
Inclusion Criteria:Patients diagnosed with head and neck cancerPersistent xerostomia after radiotherapy≥18 yearsIrradiated with radiotherapy in the major salivary glands (parotid, submandibular and sublingual)Grade 3 for dry mouth in Common Terminology Criteria for Adverse Events, CTCAE (version 5.0)Have completed medical treatment with full response (complete remission) and receive medical clearance for participation.At least one month after radiotherapy completion, to reflect the possible presence of oral mucositis (sores) and/or radiodermatitis (inflammation) that limits adherence to treatmentNo use of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers or herbs) to prevent or treat xerostomia before inclusion in the study, OR constant usage (do not change type and dosage) during 2 months before inclusion in the studyExclusion Criteria:Relapse or metastasisKarnofsky activity scale <60Contraindications to PBM therapy (cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, pregnancy)Patients with other comorbidities such as diabetes o polymedication
Source: ClinicalTrials.gov (NCT05614843). StuddyBuddy aggregates publicly available trial information.