Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT06012604
Eligibility Criteria:
Inclusion Criteria:
* squamous cell carcinoma of the oropharynx, Union for International Cancer Control TNM Classification of Malignant Tumors )8th ed.) clinical stage T1-2N+ or cT3-4cN0-3 M0, treated with curative intent radiotherapy (tumor dose 66-70 Gy, bilateral neck irradiation) with or without concurrent chemotherapy
* 2 years or more post-treatment without signs of locoregional recurrence or systemic metastasis
* non-smoker or former smoker (quit smoking ≥2 years ago)
* mean radiation dose \>26 Gy to each of the parotid glands and \>35 Gy to each of the submandibular glands
* xerostomia of grade 2 or 3, assessed according to the CTCAE v5.0 scale
* Clinically reduced salivary flow and hyposalivation (unstimulated whole saliva flow rate 0.05-0.20 ml/min)
* age between 18-75 years
* both sexes
* signed "Informed Consent Form" for participation in the study
Exclusion Criteria:
* newly diagnosed malignancy anywhere in the body within the past two years
* active smoker
* use of medications with potential to cause dry mouth (e.g., tricyclic antidepressants, antipsychotics, decongestants, bronchodilators, antihypertensives like beta-blockers and diuretics, antihistamines, hypnotic sedatives, opioids, and muscle relaxants)
* other salivary gland diseases (e.g., Sjögren's syndrome, scleroderma, sialolithiasis, etc.)
* patients on anticoagulant therapy that cannot be discontinued during the intervention
* pregnancy or planned pregnancy within the next two years
* breastfeeding
* active, uncontrolled infection or other medical (including psychiatric) conditions that, in the researchers' opinion, do not allow for the safe administration of the planned therapy and performance of the follow-up procedures
* known substance abuse or alcoholism
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06012604
Study Brief:
Protocol Section:
NCT06012604