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

Primary Purpose

Stage 0 Nasopharyngeal Carcinoma, Stage 0 Paranasal Sinus Cancer, Stage I Nasopharyngeal Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physiologic Testing
Quality-of-Life Assessment
Sham Intervention
Therapeutic Procedure
rose essential oil
lemon essential oil
clove essential oil
eucalyptus essential oil
canola oil placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage 0 Nasopharyngeal Carcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm I (olfactory training)

Arm II (sham training)

Arm Description

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.

Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
February 6, 2017
Last Updated
February 1, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03049358
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Accrual factor
Study Start Date
December 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (olfactory training)
Arm Type
Experimental
Arm Description
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 Title
Arm II (sham training)
Arm Type
Sham Comparator
Arm Description
Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Physiologic Testing
Other Intervention Name(s)
Physiologic Test, Study of Physiologic Variables
Intervention Description
Undergo UPSIT smell test
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Sham Intervention
Intervention Description
Undergo sham training
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Procedure
Other Intervention Name(s)
Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, Therapy, TREAT, Treatment
Intervention Description
Undergo olfactory training
Intervention Type
Other
Intervention Name(s)
rose essential oil
Intervention Description
patient smells rose oil in vial
Intervention Type
Other
Intervention Name(s)
lemon essential oil
Intervention Description
patient smells lemon oil in vial
Intervention Type
Other
Intervention Name(s)
clove essential oil
Intervention Description
patient smells clove oil in vial
Intervention Type
Other
Intervention Name(s)
eucalyptus essential oil
Intervention Description
patient smells eucalyptus oil in vial
Intervention Type
Other
Intervention Name(s)
canola oil placebo
Intervention Description
patient smells canola oil in vial
Primary Outcome Measure Information:
Title
Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score
Description
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
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores
Description
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
Time Frame
Baseline
Title
Improvement in quality of life related to olfactory dysfunction as measured by change in the Questionnaire of Olfactory Disorders (QOD) score
Description
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.
Time Frame
Baseline to 12 weeks
Title
Severity of olfactory dysfunction after completion of radiation therapy as measured by UPSIT score
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zara Patel
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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