A Prospective, Assessor-blinded, Randomized Study to Assess the Safety and Efficacy of Dexamethasone-Free Antiemetic Regimen in Patients Receiving Highly Emetogenic Chemotherapy (HEC) at Goa Medical College and Hospital
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete Response Rate (CRR) of Chemotherapy induced nausea and vomiting at 0 to 120 hours post-chemotherapy. Complete response is no emesis and no use of rescue antiemetics within the assessment period
研究概览
简要总结
Introduction:
Dexamethasone (DEX), a corticosteroid, is an essential component of antiemetic regimens recommended by several guidelines, including ASCO, ESMO and Multinational Association of Supportive Care in Cancer, and the NCCN, for the prophylaxis against chemotherapy-induced nausea and vomiting (CINV) for patients receiving highlyemetogenic chemotherapy (HEC)
HEC includes Anthracycline/Cyclophosphamide combination, Cisplatin, Cyclophosphamide (>1500 mg/m2), Cytarabine (1 gm/m2), Carmustine, Dacarbazine, Mechlorethamine, Streptozotocin
Despite the emergence of newer antiemetic agents, such as 5-HT3 receptor antagonists, NK-1 receptor antagonists, and olanzapine, the omission of DEX from prophylaxis for patients receiving HEC has not been studied
Cumulative dose of DEX over six cycles of HEC, can lead to potential toxicities such as insomnia, hyperglycemia, gastritis, emotional disturbance, hypertension, acne, increased appetite, and weight gain
Unlike DEX, the NK-1 antagonists are well tolerated, no long-term toxicities have been reported
NEED FOR STUDY:
Despite the availability of newer antiemetics such as 5 HT-3 and NK-1 antagonists, there are very few studies evaluating the safety and efficacy of dexamethasone (DEX)-free antiemetic regimen in patients receiving highly emetogenic chemotherapy (HEC)
Given the long term serious side effects of steroid use, there is need to evaluate safety and efficacy of dexamethasone free antiemetic regimen in oncology setting
AIMS AND OBJECTIVES:
The primary objective of the study is to compare the complete response (CR) rates for nausea and vomiting during the acute, delayed and overall period between the OPF (Olanzapine, Palenosetron, Fosaprepitant) regimen and OPD (Olanzapine, Palenosetron, Dexamethasone) regimen in patients receiving HEC
To compare Incidence of Nausea and Requirement for Breakthrough Antiemetic Medications between both groups
STUDY DESIGN:
A Prospective, Assessor-blinded, Randomized Study to Assess the Safety and Efficacy of Dexamethasone-Free Antiemetic Regimen in Patients Receiving Highly Emetogenic Chemotherapy (HEC) at Goa Medical College and Hospital
Duration of study: 1 year
INCLUSION CRITERIA:
**1)**Chemotherapy-naive patients, planned for 1st cycle of HEC
-
Age 18 to 99 years
-
Eastern Cooperative Oncology Group performance status <=2
-
Absence of nausea and vomiting 24 hours before enrollment
5)Adequate organ function
- No severe alcohol use disorder as per DSM-5
Exclusion criteria:
**1)**Patients receiving steroids as part of a chemotherapy regimen or premedication
-
Multiday chemotherapy
-
Patients in whom steroids are contraindicated (uncontrolled DM and HTN)
-
Patients with brain primary malignancy and brain metastasis
-
Treatment with another antipsychotic agent for 30 days before or during the protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Chemotherapy naive patients, planned for 1st cycle of HEC 2) Age 18 to 99 years 3) Eastern Cooperative Oncology Group performance status less than or equal to 2 4) Absence of nausea and vomiting 24 hours before enrollment 5) Adequate organ function 6) No severe alcohol use disorder as per DSM 5.
排除标准
- •Patients receiving steroids as part of a chemotherapy regimen or premedication.
- •Multiday chemotherapy 3) Patients in whom steroids are contraindicated (uncontrolled DM and HTN).
- •Patients with brain primary malignancy and brain metastasis.
- •Treatment with another antipsychotic agent for 30 days before or during the protocol.
结局指标
主要结局
Complete Response Rate (CRR) of Chemotherapy induced nausea and vomiting at 0 to 120 hours post-chemotherapy. Complete response is no emesis and no use of rescue antiemetics within the assessment period
时间窗: Acute phase: 0–24 hours post-chemotherapy | Delayed phase: 24–120 hours post-chemotherapy | Overall phase: 0–120 hours post-chemotherapy
次要结局
- Incidence of Nausea (Patient-Reported Outcomes) at 0–120 hours post-chemotherapy. Measured using a validated nausea scale(Acute (0–24h), Delayed (24–120h), Overall (0–120h))
- Requirement for Breakthrough Antiemetic Medications. Proportion of patients needing additional antiemetics post-chemotherapy(0-120 hours)
研究者
Dr Jivan Babulal Jain
Goa medical college and hospital