Clinical trial NCT03049358: Olfactory Training in Improving Sense of Smell After Radiation Therapy in Patients With Paranasal Sinus or Nasopharyngeal Cancer
Official title: Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores
timeFrame: Baseline
measure: Improvement in quality of life related to olfactory dysfunction as measured by change in the Questionnaire of Olfactory Disorders (QOD) score
timeFrame: Baseline to 12 weeks
measure: Severity of olfactory dysfunction after completion of radiation therapy as measured by UPSIT score
timeFrame: Baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Zara Patel
role: PRINCIPAL_INVESTIGATOR
References: