CTRI/2024/11/076214招募中3 期
Low-dose Olanzapine vs. Placebo in Preventing Weight Loss during Radiation for Patients with Locally Advanced HNSCC: A Double Blinded RCT
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- JIPMER
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Weight loss more than 5% from baseline
研究概览
简要总结
Purpose of the study is To compare the effect of olanzapine at a dose of 2.5 mg once a day for 12-16 weeks added to standard dietary advice in reducing the proportion who develop weight loss >5% from the baseline in patients planned for radiation (with or without concurrent chemotherapy) for Head and Neck Squamous cell carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •65 years at the time of enrolment
- •Male and Female
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •LA-HNSCC – Stage III, IVA, IVB planned for radical radiation (with or without concurrent chemotherapy)
- •Patients taking oral/enteral diet at least in liquid or semisolid form
- •Patients with Adequate organ function at time of participation, defined as Hematological: Hemoglobin more than 9gm/dl, TLC more than 4000 mm3, ANC more than 1500/mm3 ,Platelet more than 100000/mm3, Liver Function test: Bilirubin less than 2 x upper limit normal (ULN), AST/ALT/ ALP less than 2.5 x ULN, PTless than 1.5 X ULN or International Normalized Ratio less than
- •5, Renal Function test: Creatinine less than 1.5 X ULN, Creatinine, Clearance more than 60 ml/mins, Magnesium more than lower limit of normal.
排除标准
- •Earlier chemotherapy / radiotherapy
- •Intake of olanzapine in last 2 monthsfor any other indications
- •On any antipsychotic or antidepressants
- •Use of systemic corticosteroids (prednisolone 5mg or equivalent for more than 7 days in the previous 4 weeks)
- •Pregnancy
- •Any other synchronous malignancy or uncontrolled viral/bacterial infection (such as tuberculosis, hepatitis B or Hepatitis C infection)
- •Planned for adjuvant chemoradiation, Neoadjuvant chemotherapy,Psychiatric problem that required immediate attention, including acute suicidality;
- •A current diagnosis of substance abuse or dependence, schizophrenia, schizophreniform disorder, or bipolar illness
- •Neurological problem, including movement disorder (e.g., tardive dyskinesia), history of a seizure disorder, or dementia.
结局指标
主要结局
Weight loss more than 5% from baseline
时间窗: Within one week after treatment completion
次要结局
- mean change in body weight from baseline
- change in symptoms of anorexia as assessed by VAS and(FAACT-ACS)
- change in quality of life (QOL) as assessed by CI-QOL-Q(within one week of treatment completion)
- change in nutrition & calorie intake(within one week of treatment completion)
- change in body(composition parameters such as LBM, FFMI,)
- toxicity profile (highest grade) during chemoradiation(within one week of treatment completion)
- Time to develop more than 2 grade toxicities during(chemoradiation)
- drug side effect/ adverse event profile(within one week of treatment completion)
- Treatment response as assessed by RECIST(criteria)
- Event free survival & Overall survival(At 6 months of treatment completion)
研究者
研究点 (1)
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