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

NCT ID: NCT03049358

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physiologic Testing

Intervention Type: OTHER

Undergo UPSIT smell test

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Therapeutic Procedure

Intervention Type: PROCEDURE

Undergo olfactory training

rose essential oil

Intervention Type: OTHER

patient smells rose oil in vial

lemon essential oil

Intervention Type: OTHER

patient smells lemon oil in vial

clove essential oil

Intervention Type: OTHER

patient smells clove oil in vial

eucalyptus essential oil

Intervention Type: OTHER

patient smells eucalyptus oil in vial

Arm II (sham training)

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

Group Type: SHAM_COMPARATOR

Physiologic Testing

Intervention Type: OTHER

Undergo UPSIT smell test

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Sham Intervention

Intervention Type: PROCEDURE

Undergo sham training

canola oil placebo

Intervention Type: OTHER

patient smells canola oil in vial

Interventions

Physiologic Testing

Undergo UPSIT smell test

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Sham Intervention

Undergo sham training

Intervention Type: PROCEDURE

Therapeutic Procedure

Undergo olfactory training

Intervention Type: PROCEDURE

rose essential oil

patient smells rose oil in vial

Intervention Type: OTHER

lemon essential oil

patient smells lemon oil in vial

Intervention Type: OTHER

clove essential oil

patient smells clove oil in vial

Intervention Type: OTHER

eucalyptus essential oil

patient smells eucalyptus oil in vial

Intervention Type: OTHER

canola oil placebo

patient smells canola oil in vial

Intervention Type: OTHER

Other Intervention Names

Physiologic Test; Study of Physiologic Variables; Quality of Life Assessment; Therapeutic Interventions; Therapeutic Method; Therapeutic Technique; Therapy; TREAT; Treatment

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
• Pregnant women will be excluded; nursing patients will be included

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zara Patel

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Countries

United States

Other Identifiers

NCI-2017-00147

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-39817

Identifier Type: OTHER

Identifier Source: secondary_id

ENT0059

Identifier Type: -

Identifier Source: org_study_id