Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 106
- 试验地点
- 20
- 主要终点
- Response
研究概览
简要总结
This phase III trial compares rose geranium in sesame oil nasal spray to isotonic nasal saline in improving symptoms of nasal vestibulitis in cancer patients receiving chemotherapy. Nasal (nose) symptoms (dryness, discomfort, bleeding, scabbing or sores) due to inflammation, termed nasal vestibulitis, is reported as a side effect of cancer-directed therapy. Rose geranium in sesame oil nasal spray may work better than isotonic nasal saline in improving symptoms of nasal vestibulitis.
详细描述
PRIMARY OBJECTIVE:
I. To determine the ability of rose geranium in sesame oil nasal spray to alleviate nasal vestibulitis in patients undergoing systemic, antineoplastic therapy when compared with isotonic nasal saline.
SECONDARY OBJECTIVE:
I. To assess toxicities related to rose geranium in sesame oil nasal spray in this study situation.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •REGISTRATION-INCLUSION CRITERIA
- •Age >= 18 years and be diagnosed with cancer and receiving chemotherapy
- •Ability to provide informed consent
- •Willingness to complete questionnaires
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
- •One or more of the following nasal symptoms for which the patient reports they would appreciate treatment. Symptoms must have started after the initiation of systemic, antineoplastic therapies, be attributed to the systemic, antineoplastic therapies, and symptoms must be reported as being moderate (corresponding to a score of 2) or worse on a scale from mild (1) to very severe (4) on at least one of the items below.
- •Discomfort/pain
排除标准
- •REGISTRATION-EXCLUSION CRITERIA
- •Predisposition to epistaxis prior to the initiation of cancer-directed therapy (more than once a month over the previous year)
- •Planned initiation or continuation of any topical nasal treatment other than the studied nasal spray,(such as nasal steroids, Ayr nasal gel, Neosporin ointment or nasal administration of petroleum jelly). Taking Imitrex for migraines is acceptable
- •Previous exposure to rose geranium in sesame oil nasal spray
- •Concurrent upper respiratory tract infection
- •History of allergic or other adverse reactions to sesame oil or essential rose geranium oil
- •Any other reason that the study clinician or investigator feels precludes safe or appropriate inclusion in this study
- •Vulnerable populations: pregnant women, prisoners, mentally handicapped
- •RE-REGISTRATION
- •The patient will be un-blinded and determined to have been on the saline arm, when initially randomized
研究组 & 干预措施
Arm A (rose geranium in sesame oil nasal spray)
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm A (rose geranium in sesame oil nasal spray)
Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.
干预措施: Rose Geranium in Sesame Oil Nasal Spray (Drug)
Arm B (isotonic nasal saline)
Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.
干预措施: Placebo Administration (Drug)
Arm B (isotonic nasal saline)
Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Response
时间窗: At 2 weeks after initiating the nasal spray
Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating\>\>\> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test.
次要结局
- Severity of Most Prominent Nasal Symptom Indicated at Baseline(Up to 2 weeks after initiating the nasal spray)
- Nasal Symptom Analysis(Up to 2 weeks after initiating the nasal spray)
- Number of Participants With Adverse Events (AEs)(Up to 2 weeks after initiating the nasal spray)