Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Physiologic Testing (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Therapeutic Procedure (Procedure)
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.
干预措施: rose essential oil (Other)
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.
干预措施: lemon essential oil (Other)
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.
干预措施: clove essential oil (Other)
Arm II (sham training)
Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
干预措施: Physiologic Testing (Other)
Arm II (sham training)
Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
干预措施: Quality-of-Life Assessment (Other)
Arm II (sham training)
Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
干预措施: Sham Intervention (Procedure)
Arm II (sham training)
Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.
干预措施: canola oil placebo (Other)
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.
干预措施: eucalyptus essential oil (Other)
结局指标
主要结局
Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score
时间窗: 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
次要结局
- Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores(Baseline)
- 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)
- Severity of olfactory dysfunction after completion of radiation therapy as measured by UPSIT score(Baseline)