Study Stopped
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Olfactory Training in Improving Sense of Smell After Radiation Therapy in Patients With Paranasal Sinus or Nasopharyngeal Cancer
Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma
3 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedFebruary 5, 2019
February 1, 2019
1.8 years
February 6, 2017
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score
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
Baseline to 12 weeks
Secondary Outcomes (3)
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
Study Arms (2)
Arm I (olfactory training)
EXPERIMENTALPatients 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 (sham training)
SHAM COMPARATORPatients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
Interventions
Undergo UPSIT smell test
Ancillary studies
Undergo olfactory training
Eligibility Criteria
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
- Pregnant women will be excluded; nursing patients will be included
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University, School of Medicine
Palo Alto, California, 94304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zara Patel
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 10, 2017
Study Start
December 1, 2016
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
February 5, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share