PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in MAT (MASCC Antiemesis Tool) score
研究概览
简要总结
Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to patient care and continues to decrease quality of life. Despite the addition of medications and antiemetic regimens, doctors' ability to control CINV is still inadequate: even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea. In this study, the investigators test a transcranial vibrating system that has shown great promise at reducing nausea and vomiting. .
详细描述
Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to cancer patient care despite numerous medications being available to prevent and treat CINV.
CINV decreases quality of life in roughly one third of patients receiving highly emetogenic chemotherapy. In addition, roughly half to two thirds of all patients receiving chemotherapy require rescue anti-emetic medications despite being given guideline-based prophylactic anti-emetics.The anti-emesis armamentarium continues to grow with new medications, including olanzapine and fosaprepitant, being studied in recent years. However, despite the addition of these medications and guideline-based antiemetic regimens, the ability to control CINV is still inadequate as even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea.
In this study, the investigators aim to test a new transcranial vibrating system that has shown promise in phase I studies for treating dizziness, motion sickness and nausea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The sponsor will be randomly assigning the Otoband or placebo device to participants. The investigator will not know which device is assigned.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject currently receiving chemotherapy known to be emetogenic (i.e subject has already received one round of chemotherapy)
- •MASCC Antiemesis Tool score of > 6 on the nausea severity scale and/or
- •One or more episodes of vomiting anytime in the 4 days following receipt of chemotherapy and/or
- •The need for three or more uses of rescue antiemetic medications within 4 days of chemotherapy during previous round.
排除标准
- •Pregnant women
- •Individuals unable to provide informed consent
- •Any preexisting condition causing significant nausea or vomiting, or causing reaction to the bone conduction system (e.g. superior canal dehiscence)
- •Prisoners
结局指标
主要结局
Change in MAT (MASCC Antiemesis Tool) score
时间窗: MAT score is obtained on day 5 following each of the three chemotherapy treatments.
Potential subjects will be screened for eligibility based on their responses to the (standard of care) questionnaire developed by the "Multinational Association for Supportive Care in Cancer" and called the MAT (Multinational Antiemesis Tool). MAT scores range from 0 (no issue) to 10 (most severe). Any difference in severity of nausea as measured by MAT score between active and placebo phases, and compared to the scores obtained in the pre-trial round of chemotherapy, will be analyzed.
次要结局
- Change in number of episodes of vomiting(For the 5 days following each of the two chemotherapy infusions, with effective and placebo devices.)
- Change in amount of rescue antiemetics required to control chemotherapy-induced nausea and vomiting(For the 5 days following each of the two chemotherapy treatment.)
- Change in population of "Complete responders"(For the 5 days following each of the two each chemotherapy treatment)