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

Not Applicable

Terminated

• Conditions: Stage IIB Nasopharyngeal Carcinoma; Stage IVA Nasopharyngeal Carcinoma; Stage IVB Nasopharyngeal Carcinoma; Stage IVB Paranasal Sinus Cancer; Stage II Paranasal Sinus Cancer; Stage III Paranasal Sinus Cancer; Stage IV Nasopharyngeal Carcinoma; Stage IVC Nasopharyngeal Carcinoma; Stage 0 Paranasal Sinus Cancer; Stage I Nasopharyngeal Carcinoma
• Interventions: Other: Physiologic Testing; Other: Quality-of-Life Assessment; Procedure: Sham Intervention; Procedure: Therapeutic Procedure; Other: rose essential oil; Other: canola oil placebo; Other: lemon essential oil; Other: clove essential oil; Other: eucalyptus essential oil

• Registration Number: NCT03049358
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (sham training)	Sham Intervention	Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
Arm I (olfactory training)	Physiologic Testing	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 I (olfactory training)	Quality-of-Life Assessment	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 I (olfactory training)	Therapeutic Procedure	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 I (olfactory training)	lemon essential oil	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 I (olfactory training)	rose essential oil	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 I (olfactory training)	clove essential oil	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 I (olfactory training)	eucalyptus essential oil	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 (sham training)	Physiologic Testing	Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
Arm II (sham training)	Quality-of-Life Assessment	Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
Arm II (sham training)	canola oil placebo	Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score	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

Name	Time	Method
Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores	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	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	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

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States