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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

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.

Condition or disease Intervention/treatment Phase
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 Other: Physiologic Testing Other: Quality-of-Life Assessment Procedure: Sham Intervention Procedure: Therapeutic Procedure Other: rose essential oil Other: lemon essential oil Other: clove essential oil Other: eucalyptus essential oil Other: canola oil placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma
Actual Study Start Date : December 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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: 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

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.
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

Other: canola oil placebo
patient smells canola oil in vial




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049358


Locations
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United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Zara Patel Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03049358     History of Changes
Other Study ID Numbers: ENT0059
NCI-2017-00147 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-39817 ( Other Identifier: Stanford IRB )
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Paranasal Sinus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Nose Neoplasms
Respiratory Tract Neoplasms
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases