An open label randomized trial of comparison of addition of Olanzapine 5 mg versus Olanzapine 10 mg as anti-emetic to standard anti-emetic regime for Doxorubicin and Cyclophosphamide in breast cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- The primary outcome is complete response (proportion of patients do not report nausea and vomiting) within 120 hours (05 days) after initiation of chemotherapy.
研究概览
简要总结
| Introduction: Chemotherapy induced nausea and vomiting are the commonest side effects. While standard triple antiemetics are prescribed for breast cancer (aprepitant, ondansetron and dexamethasone), Olanzapine, an antipsychotic, has been found to reduce chemotherapy induced nausea and vomiting by 25-50%. This response has been reported in more than 85-90% of patients receiving chemotherapy in breast cancer. However, very little is known if Olanzapine 5 mg is as effective as Olanzapine 10 mg, and if dose is related to common side effects – somnolence and fatigue. |
Objectives: This study intends to assess the safety and efficacy of oral Olanzapine 5 mg versus Olanzapine 10 mg as antiemetic in the prevention and treatment of nausea and vomiting when added to standard regime for Doxorubicin and Cyclophosphamide chemotherapy in breast cancer.
Methods: This is an open label randomized clinical trial conducted among patients with breast cancer receiving chemotherapy with Doxorubicin and Cyclophosphamide at a malignant disease treatment centre in Western Maharashtra, India. Olanzapine 5 mg or 10 mg PO will be added for four days to standard antiemetic therapy. Eligible patients will be randomized through random sequence generation into two equivalence arm with a 1:1 allocation. With expected success rate of at 87.9% in each arm and equivalence limit of 20 and allowance for attrition of 10 per arm, the sample size is 59 per arm, total of 118 subjects. Informed written consent will be taken to extract patient and chemotherapy related details from patient records. Primary outcome of nausea and vomiting will be assessed using the Rhodes Index and the MASCC Antiemetic Tool through serial interviews. Data will be entered into EpiData 3.1 and descriptive statistics used to describe the outcomes.
Results: The proportion of complete response (absence of) of nausea and vomiting will be described. If not complete response, the time to nausea and vomiting will be described in Kaplan-Meir curve.
Conclusion: Efficacy of Olanzapine 5 mg vs 10 mg in producing complete response to prevention and treatment of chemotherapy induced nausea and vomiting. Proportion of somnolence and fatigue in the two arms.
Trail registration: CTRI (process initiated).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •This study will include patients receiving doxorubicin and cyclophosphamide regimen in the adjuvant setting and those who were on olanzapine as one of the antiemetic prophylaxis: Adults aged 18 years and above; Chemotherapy-naive breast cancer of any stage; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (19); Written informed consent; Able to understand and describe patient-reported outcomes.
- •Subjects who were on medications such as antibiotics and motility enhancers such as metoclopramide shall be included after a washout period of 7 days.
排除标准
- •This study will exclude the following subjects: Scheduled to receive abdominal or pelvic radiotherapy within 8 days of Day 1 of the study; Acute surgical conditions such as gastrointestinal obstruction, appendicitis, and pancreatitis; History of hypersensitivity or allergy to any of the study drugs or similar compounds; Symptomatic brain metastasis, or gastrointestinal tumours; Liver and renal function derangements; Left ventricular ejection fraction <50%; Documented Parkinson’s disease; Patients on antipsychotic drugs such as chlorpromazine, risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone; Patients on antiepileptic drugs; Pregnant or breastfeeding women and women of childbearing potential, as well as men wishing to father children; Habitual smoking; History of using any of the following drugs within 48 h before enrolment: opioids, aprepitant, 5-HT3-RA, dexamethasone, dopamine receptor antagonists, antihistamines, benzodiazepines or phenothiazine antipsychotic agents.
结局指标
主要结局
The primary outcome is complete response (proportion of patients do not report nausea and vomiting) within 120 hours (05 days) after initiation of chemotherapy.
时间窗: The primary outcome is complete response (proportion of patients do not report nausea and vomiting) within 120 hours (05 days) after initiation of chemotherapy.
次要结局
- The secondary outcomes are complete response rates in the acute phase (0 – 24 h), delayed phase (24 – 120 h) and the overall phase (0 – 120 h); time to treatment failure; and selected adverse reactions due to the regimen.(The secondary outcomes are complete response rates in the acute phase (0 – 24 h), delayed phase (24 – 120 h) and the overall phase (0 – 120 h); time to treatment failure; and selected adverse reactions due to the regimen.)