Stage 0 Nasopharyngeal CarcinomaNCT03049358
Olfactory Training in Improving Sense of Smell After Radiation Therapy in Patients With Paranasal Sinus or Nasopharyngeal Cancer
A study testing Physiologic Testing, Quality-of-Life Assessment and Therapeutic Procedure in people with Stage 0 Nasopharyngeal Carcinoma and Stage 0 Paranasal Sinus Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stage 0 Nasopharyngeal Carcinoma, Stage 0 Paranasal Sinus Cancer, Stage I Nasopharyngeal Carcinoma
- What is being tested?
- Physiologic Testing, Quality-of-Life Assessment and Therapeutic Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- Physiologic Testing, Quality-of-Life Assessment, Sham Intervention, Therapeutic Procedure, rose essential oil
- Medical subject headings
- Nasopharyngeal Carcinoma, Paranasal Sinus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiologic TestingOther
Also called Physiologic Test, Study of Physiologic Variables
Undergo UPSIT smell test
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Sham InterventionProcedure or surgery
Undergo sham training
Therapeutic ProcedureProcedure or surgery
Also called Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, Therapy
Undergo olfactory training
rose essential oilOther
patient smells rose oil in vial
lemon essential oilOther
patient smells lemon oil in vial
clove essential oilOther
patient smells clove oil in vial
eucalyptus essential oilOther
patient smells eucalyptus oil in vial
canola oil placeboOther
patient smells canola oil in vial
| Study group | Role | What they receive |
|---|---|---|
| Arm I (olfactory training) | Experimental | 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. Receives: 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 |
| Arm II (sham training) | Sham comparator | Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks. Receives: Other: Physiologic Testing; Other: Quality-of-Life Assessment; Procedure: Sham Intervention; Other: canola oil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score
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
Measured: Baseline to 12 weeks
Secondary outcomes (3)
Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores
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
Measured: Baseline
Improvement in quality of life related to olfactory dysfunction as measured by change in the Questionnaire of Olfactory Disorders (QOD) score
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.
Measured: Baseline to 12 weeks
Severity of olfactory dysfunction after completion of radiation therapy as measured by UPSIT score
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startDec 2016
- Primary completionOct 2018
- Study completionOct 2018
Why it stopped: Accrual factor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 0 Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zara Patel, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049358
- Sponsor's protocol ID
- ENT0059
- Other IDs
- NCI-2017-00147, IRB-39817
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03049358
- Acronym / sponsor ID
- ENT0059
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual factor
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (olfactory training) | Experimental | 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 oilPatients 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) | Sham comparator | Other: Physiologic Testing, Other: Quality-of-Life Assessment, Procedure: Sham Intervention, Other: canola oil placeboPatients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- No therapy restrictions
- No restrictions on use of other investigational agents
- Co-morbid disease or incurrent illness such as:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiologic TestingAlso: Physiologic Test, Study of Physiologic VariablesUndergo UPSIT smell test | Other | Arm I (olfactory training), Arm II (sham training) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (olfactory training), Arm II (sham training) |
| Sham InterventionUndergo sham training | Procedure or surgery | Arm II (sham training) |
| Therapeutic ProcedureAlso: Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, TherapyUndergo olfactory training | Procedure or surgery | Arm I (olfactory training) |
| rose essential oilpatient smells rose oil in vial | Other | Arm I (olfactory training) |
| lemon essential oilpatient smells lemon oil in vial | Other | Arm I (olfactory training) |
| clove essential oilpatient smells clove oil in vial | Other | Arm I (olfactory training) |
| eucalyptus essential oilpatient smells eucalyptus oil in vial | Other | Arm I (olfactory training) |
| canola oil placebopatient smells canola oil in vial | Other | Arm II (sham training) |
Primary outcome
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
3 secondary outcomes
Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores
Time frame: Baseline
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
Severity of olfactory dysfunction after completion of radiation therapy as measured by UPSIT score
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Accrual factor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zara Patel principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiologic Testing, Quality-of-Life Assessment and Therapeutic Procedure in people with Stage 0 Nasopharyngeal Carcinoma and Stage 0 Paranasal Sinus Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Accrual factor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.