Olanzapine to improve cancer anorexia cachexia syndrome in patients with Cervix Carcinoma undergoing Radiotherapy with concurrent Cisplatin – a prospective randomised study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Cancer Anorexia-Cachexia Syndrome is common in cervical cancer and worsened by chemoradiation. Low-dose olanzapine is endorsed in advanced cancer, but evidence during definitive chemoradiation is scarce. To our knowledge, this is the first study to evaluate olanzapine in carcinoma cervix
It is a Single-centre, prospective, randomized, placebo-controlled trial in treatment-naïve cervical cancer planned for radical radiotherapy with weekly cisplatin. Arm A will receive olanzapine 2.5 mg once daily for 12 weeks; Arm B will received placebo. Primary outcomes: change in appetite (VAS, FAACT-ACS) and weight. Secondary: quality of life (FAACT-G). Assessments at baseline, during treatment, and at 8 weeks; ethics approval obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 69.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient should be treatment naive, Eastern Cooperative Oncology Group Perfomance Status scale (ECOG PS) should be between 0-2, FIGO STAGE (2021) 1-4, NO MAJOR LIFE THREATENING COMORBODITIES, BASELINE NORMAL BLOOD PARAMETERS.
排除标准
- •PATIENTS ON LONG TERM STEROIDS, Patients with PSYCHIATRIC ILLNESS, DENIAL OF CONSENT, PATIENTS WITH METABOLIC SYNDROME, PREGANCY AND LACTATION PATIENTS, BMI LESS THAN 18.5.
研究者
Abhishek Basu
Burdwan Medical College and Hospital