Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/Dexamethasone With or Without Dronabinol for the Prevention of Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Number of Participants With Total Protection in the Acute, Delayed and Overall Periods
研究概览
简要总结
The goal of this clinical research study is to learn if adding dronabinol in combination with the standard of care (dexamethasone and palonosetron) can better help to control nausea and vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be studied.
详细描述
The Study Drugs:
Dronabinol and palonosetron are both designed to help prevent nausea and vomiting in patients who are receiving chemotherapy.
Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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
- •Histologically or cytologically documented solid tumor
- •Receiving moderately emetogenic chemotherapy for the first time: Patients may be chemotherapy naive, or patients may have previously received a mildly emetogenic agent (such as a taxane) if no nausea/vomiting was experienced with that chemotherapy
- •Scheduled to receive cyclophosphamide </= 1500 mg/m^2 IV and/or doxorubicin >/= 40 mg/m^2 IV given as single doses on Day
- •Patients on combination regimens with these agents are eligible
- •Age >/= 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Adequate organ reserve as follows: 1) Hematologic - white blood cell count (WBC) >/= 3000/microL, AGC >/= 1500/microL, platelet >/= 100,000/microL; 2) Renal - Creatinine </= 1.5 times upper limit of normal; 3) Hepatic - Bilirubin and transaminases </= 2.5 times upper limit of normal
- •The effects of the three-drug regimen on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Negative qualitative B-human chorionic gonadotropin (HCG) (pregnancy test)
- •Signed informed consent
排除标准
- •Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 - such as cisplatin, streptozotocin, dacarbazine, carmustine, hexamethylmelamine, mechlorethamine, procarbazine) during the study period
- •Scheduled to receive moderately emetogenic chemotherapy (Hesketh Level 3-4) after Day 1 of the study period
- •Experienced nausea and/or vomiting with prior administration of chemotherapy
- •Prior moderately or highly emetogenic chemotherapy: Patients may have previously received a mildly emetogenic agent (such as a taxane) if no nausea/vomiting was experienced with that chemotherapy
- •Scheduled to receive cranial, abdominal, or pelvic radiation therapy during the study period
- •Treatment with any investigational agent within 30 days of randomization
- •Scheduled to receive treatment during the study period with other potential or known antiemetic agents. Chronically used benzodiazepines may be continued as a single nightly dose for sleep.
- •Scheduled to receive corticosteroid treatment other than the study drug dose during the study period
- •Uncontrolled primary or metastatic CNS tumor (including those with uncontrolled seizures)
- •Other physical causes for nausea or vomiting (such as bowel obstruction) not related to chemotherapy administration
- •Recent history of unexplained nausea or vomiting or history of frequent nausea or vomiting
- •Active bacterial or fungal infection for which administration of a corticosteroid would be contraindicated
- •Hypersensitivity to any of the study agents
- •Sensitivity to sesame oil
- •Planned simultaneous administration of any other investigational agents
- •Pregnant or nursing women
- •Previous poor tolerance of cannabinoids
- •Habitual cannabinoid use or unwillingness to avoid the use of marijuana during the study period
- •Previous use of dronabinol or nabilone
研究组 & 干预措施
Arm I: Palonosetron, Dexamethasone + Dronabinol
Palonosetron hydrochloride intravenous (IV) and dexamethasone IV 30 minutes before chemotherapy administration on day 1, and oral dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy administration on day 1.
干预措施: palonosetron hydrochloride (Drug)
Arm II: Palonosetron + Dexamethasone
Palonosetron hydrochloride and dexamethasone as in arm I, and oral placebo 3 times a day for 5 days beginning 30 minutes before chemotherapy on day 1.
干预措施: dexamethasone (Drug)
Arm I: Palonosetron, Dexamethasone + Dronabinol
Palonosetron hydrochloride intravenous (IV) and dexamethasone IV 30 minutes before chemotherapy administration on day 1, and oral dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy administration on day 1.
干预措施: dexamethasone (Drug)
Arm I: Palonosetron, Dexamethasone + Dronabinol
Palonosetron hydrochloride intravenous (IV) and dexamethasone IV 30 minutes before chemotherapy administration on day 1, and oral dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy administration on day 1.
干预措施: dronabinol (Drug)
Arm II: Palonosetron + Dexamethasone
Palonosetron hydrochloride and dexamethasone as in arm I, and oral placebo 3 times a day for 5 days beginning 30 minutes before chemotherapy on day 1.
干预措施: palonosetron hydrochloride (Drug)
Arm II: Palonosetron + Dexamethasone
Palonosetron hydrochloride and dexamethasone as in arm I, and oral placebo 3 times a day for 5 days beginning 30 minutes before chemotherapy on day 1.
干预措施: placebo (Other)
结局指标
主要结局
Number of Participants With Total Protection in the Acute, Delayed and Overall Periods
时间窗: 5 Days (first 5 days of the first cycle of chemotherapy)
Total protection is defined as no vomiting, no rescue therapy, and no nausea as indicated by responses to the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. Data to be recorded in the study diary during the 5-day study period. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
次要结局
- Number of Participants With Complete Protection for the Acute, Delayed, and Overall Periods(Up to 5 days (first 5 days following first cycle of chemotherapy))
- Number of Participants With Complete Response for the Acute, Delayed, and Overall Periods(Up to 5 days (first 5 days following first cycle of chemotherapy))
- Number of Participants With Vomiting for the Acute, Delayed and Overall Periods(5 Days (first 5 days of the first cycle of chemotherapy))
- Number of Participants With Nausea for the Acute, Delayed and Overall Periods(5 Days (first 5 days of the first cycle of chemotherapy))
- Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods(5 Days (first 5 days of the first cycle of chemotherapy))
- Number of Participants Received Rescue Medication in the Acute, Delayed and Overall Periods(5 Days (first 5 days of the first cycle of chemotherapy))