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

Stage IV Nasopharyngeal Carcinoma Clinical Trial

Official title:

Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03049358
• Other study ID #: ENT0059
• Secondary ID: NCI-2017-00147IR
• Status: Terminated
• Phase: N/A
• Start date: December 2016
• Est. completion date: October 2018

Study information

• Verified date: February 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Neoplasms
• Paranasal Sinus Neoplasms
• 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

Intervention

Other:
• Physiologic Testing
Undergo UPSIT smell test
• Quality-of-Life Assessment
Ancillary studies

Procedure:
• Sham Intervention
Undergo sham training
• Therapeutic Procedure
Undergo olfactory training

Other:
• rose essential oil
patient smells rose oil in vial
• lemon essential oil
patient smells lemon oil in vial
• clove essential oil
patient smells clove oil in vial
• eucalyptus essential oil
patient smells eucalyptus oil in vial
• canola oil placebo
patient smells canola oil in vial

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores	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
Secondary	Improvement in quality of life related to olfactory dysfunction as measured by change in the Questionnaire of Olfactory Disorders (QOD) score	Within each subgroup of participants, change in QOD score after olfactory training will be calculated and compared between treatment and control group. Confidence interval (CI) 95% and P value < 5% will be set as statistical parameters to define if noted difference is significant. Based on previous studies, a change of >= 1/2 standard deviation of the pre-treatment score would be clinically significant.	Baseline to 12 weeks
Secondary	Severity of olfactory dysfunction 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. 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. These statistics will be shown	Baseline