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

Stanford University

Status

Terminated

Conditions

Stage IVB Paranasal Sinus Cancer

Stage I Nasopharyngeal Carcinoma

Stage III Paranasal Sinus Cancer

Stage II Nasopharyngeal Carcinoma

Stage IVC Paranasal Sinus Cancer

Stage IIA Nasopharyngeal Carcinoma

Stage IVA Nasopharyngeal Carcinoma

Stage IIB Nasopharyngeal Carcinoma

Stage IVA Paranasal Sinus Cancer

Stage II Paranasal Sinus Cancer

Stage IVB Nasopharyngeal Carcinoma

Stage I Paranasal Sinus Cancer

Stage III Nasopharyngeal Carcinoma

Stage 0 Nasopharyngeal Carcinoma

Stage IVC Nasopharyngeal Carcinoma

Stage IV Nasopharyngeal Carcinoma

Stage IV Paranasal Sinus Cancer

Stage 0 Paranasal Sinus Cancer

Treatments

Other: canola oil placebo

Other: lemon essential oil

Other: eucalyptus essential oil

Other: Physiologic Testing

Other: Quality-of-Life Assessment

Other: rose essential oil

Procedure: Therapeutic Procedure

Other: clove essential oil

Procedure: Sham Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03049358

IRB-39817 (Other Identifier)

ENT0059

NCI-2017-00147 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

19+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups

Arm I (olfactory training)

Experimental group

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.

Treatment: