Olfactory Training in Improving Sense of Smell After Radiation Therapy in Patients With Paranasal Sinus or Nasopharyngeal Cancer

Stopped early · Not applicable · Has a placebo group

Conditions studied: Stage 0 Nasopharyngeal Carcinoma, Stage 0 Paranasal Sinus Cancer, Stage I Nasopharyngeal Carcinoma, Stage I Paranasal Sinus Cancer, Stage II Nasopharyngeal Carcinoma, Stage II Paranasal Sinus Cancer, Stage IIA Nasopharyngeal Carcinoma, Stage IIB Nasopharyngeal Carcinoma, Stage III Nasopharyngeal Carcinoma, Stage III Paranasal Sinus Cancer, Stage IV Nasopharyngeal Carcinoma, Stage IV Paranasal Sinus Cancer, Stage IVA Nasopharyngeal Carcinoma, Stage IVA Paranasal Sinus Cancer, Stage IVB Nasopharyngeal Carcinoma, Stage IVB Paranasal Sinus Cancer, Stage IVC Nasopharyngeal Carcinoma, Stage IVC Paranasal Sinus Cancer

In brief

This randomized phase I trial studies how well olfactory training works in improving sense of smell after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer. Olfactory training may improve smell function after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer.

Key facts

Study ID

NCT03049358

Run by

Stanford University

People needed

15

Starts

2016-12-01

Expected to finish

2018-10-01

Last updated by the study team

2019-02-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University, School of Medicine — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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