Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stage 0 Nasopharyngeal Carcinoma
- Sponsor
- Stanford University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the effect of olfactory training on olfactory function in patients with paranasal sinus and nasopharyngeal carcinoma suffering from olfactory loss after radiation. SECONDARY OBJECTIVES: I. To evaluate the possible effect of olfactory training on quality of life in patients with paranasal sinus and nasopharyngeal carcinoma suffering from olfactory loss after radiation. II. To study rate and severity of olfactory dysfunction after radiation therapy in patients with paranasal sinus or nasopharyngeal carcinoma. III. To evaluate the possible preventive effect of olfactory training on olfactory dysfunction in patients with paranasal sinus and nasopharyngeal carcinoma who will undergo radiation therapy. OUTLINE: Patients are randomized to 1 of 2 arms. Arm I: Patients undergo olfactory training by smelling 4 essential oils in vials (rose, lemon, clove, and eucalyptus) over 15 seconds each, twice daily for 12 weeks. Arm II: Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
Investigators
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
Outcomes
Primary Outcomes
Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score
Time Frame: Baseline to 12 weeks
T-test or Mann-Whitney U test, where appropriate, will be used for comparing continuous variables, and chi-squared test will be used for comparing categorical variables. Continuous UPSIT score will be summarized using the following statistics: number of subjects, arithmetic mean, standard deviation, median, first quartile, third quartile, minimum, and maximum values. The dependent variable UPSIT score will be either the percent change from baseline or change from baseline in the endpoint. Mixed model repeated measures (MMRM) analysis will be used and the model will included fixed effect terms
Secondary Outcomes
- Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores(Baseline)
- Improvement in quality of life related to olfactory dysfunction as measured by change in the Questionnaire of Olfactory Disorders (QOD) score(Baseline to 12 weeks)
- Severity of olfactory dysfunction after completion of radiation therapy as measured by UPSIT score(Baseline)