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

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ClinicalTrials.gov Identifier: NCT03049358
Recruitment Status : Terminated (Accrual factor)
First Posted : February 10, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE February 6, 2017
First Posted Date  ICMJE February 10, 2017
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03049358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores [ Time Frame: Baseline ]
    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 [ Time Frame: Baseline to 12 weeks ]
    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 [ Time Frame: Baseline ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olfactory Training in Improving Sense of Smell After Radiation Therapy in Patients With Paranasal Sinus or Nasopharyngeal Cancer
Official Title  ICMJE Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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  ICMJE
  • Other: Physiologic Testing
    Undergo UPSIT smell test
    Other Names:
    • Physiologic Test
    • Study of Physiologic Variables
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Procedure: Sham Intervention
    Undergo sham training
  • Procedure: Therapeutic Procedure
    Undergo olfactory training
    Other Names:
    • Therapeutic Interventions
    • Therapeutic Method
    • Therapeutic Technique
    • Therapy
    • TREAT
    • Treatment
  • Other: rose essential oil
    patient smells rose oil in vial
  • Other: lemon essential oil
    patient smells lemon oil in vial
  • Other: clove essential oil
    patient smells clove oil in vial
  • Other: eucalyptus essential oil
    patient smells eucalyptus oil in vial
  • Other: canola oil placebo
    patient smells canola oil in vial
Study Arms  ICMJE
  • Experimental: Arm I (olfactory training)
    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.
    Interventions:
    • Other: Physiologic Testing
    • Other: Quality-of-Life Assessment
    • Procedure: Therapeutic Procedure
    • Other: rose essential oil
    • Other: lemon essential oil
    • Other: clove essential oil
    • Other: eucalyptus essential oil
  • Sham Comparator: Arm II (sham training)
    Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
    Interventions:
    • Other: Physiologic Testing
    • Other: Quality-of-Life Assessment
    • Procedure: Sham Intervention
    • Other: canola oil placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 1, 2019)
15
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
120
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03049358
Other Study ID Numbers  ICMJE ENT0059
NCI-2017-00147 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-39817 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zara Patel Stanford University
PRS Account Stanford University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP