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:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT03049358
Eligibility Criteria:
Inclusion Criteria:
* Eligible disease(s)/stage(s): nasopharyngeal carcinoma, paranasal sinus cancers/any stage
* Patients with paranasal sinus or nasopharyngeal carcinoma who are about to undergo radiation therapy; patients with paranasal sinus or nasopharyngeal carcinoma who have completed radiation therapy 3-6 months prior to enrollment who then show olfactory loss on a screening test (University of Pennsylvania Smell Identification Test \[UPSIT\] - score of 34 or 33 or lower out of 40, depending on female/male); both those patients undergoing chemotherapy and those who did not will be eligible, and this factor will be assessed as a possible confounder/contributor in a multi-regression analysis
* No race-ethnic restriction
* No life expectancy restriction
* No need for Karnofsky performance status
* Only requirement for organ function is for patients to have competency to consent and participate in the study; in the arm of the study which requires patients to have olfactory dysfunction before enrollment, an UPSIT score will be used to identify these patients
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* No therapy restrictions
* No restrictions on use of other investigational agents
* Co-morbid disease or incurrent illness such as:
* History of head trauma
* History of nasal surgery other than biopsy (before cancer was diagnosed)
* History of sinus surgery other than biopsy (before cancer was diagnosed)
* Chronic rhinosinusitis with or without polyp
* Pregnancy
* Cognitive dysfunction
* History of brain surgery
* Psychiatric or neurologic diseases interfering with sense of smell
* Congenital disorders of olfactory dysfunction
* Olfactory loss prior to onset of nasopharyngeal carcinoma
* No allergic reactivity has been associated with olfactory training and thus there is no need for any exclusion criteria related to this
* No other agents have any possible potentiation or decreased activity related to olfactory training and thus there is no need for any exclusion criteria related to this
* There are no other agent-specific exclusion criteria
* Pregnant women will be excluded; nursing patients will be included
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03049358
Study Brief:
Protocol Section:
NCT03049358