An open-label,phase III randomized control trial to observe the weight gain and appetite improvement with use of Megestrol in advanced stage cancer patients having anorexia and cachexia syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
An open label, randomized control trial to observe the weight gain and appetite improvement with use of megestrol in advanced stage cancer patients having anorexia cachexia syndrome. ACS is a combination of anorexia (loss of appetite) and atrophy (decrease in size and wasting of body part) of adipose and skeletal muscle, which affects nearly 35-40% of patients with advanced-stage cancer. Megestrol Acetate (MA) is commonly used to treat ACS, and its effectiveness has been proven in several studies. However, there is no consensus on the optimal dosage of MA, which could cause toxicity in patients, resulting in additional problems like skeletal muscle loss, sarcopenia, and physical frailty. This study aims to determine the optimal dose of MA to treat ACS with the least toxicity possible. The study will help understand the appropriate dosage of MA that can show effects without causing harmful side effects or increasing the economic burden to the patient.
Objectives:
Primary Objective –
- To compare the safety and efficacy (weight gain and appetite improvement) of megestrol when given in two doses,160mg/day or 480mg/day to advance stage cancer patients with anorexia-cachexia syndrome.
Secondary Objectives –
-
To observe the adverse drug reaction in both arms.
-
To compare quality of life in both arms.
Methodology:
The study will be conduct for the period of 2 year and the participants in the study will be randomize into two arms –
1. 1. Arm A – In Arm A, participants will receive oral megestrol of total dose of 480mg/day for 12 weeks.
2. Arm B – In Arm B, participants will receive oral megestrol of total dose 160mg/day for 12 weeks.
In both arms, patients will receive treatment for 12 weeks and will be followed-up for 4 weeks to assess the efficacy and toxicities of treatment.
Outcome Measure:
Primary outcome –
- To compare weight and appetite improvement in participants in both arms.
Secondary Outcome –
-
To compare quality of life at baseline and 4 weekly till the primary endpoint.
-
To compare adverse events in both arms.
In both arms, patients will be given treatment and accessed for efficacy, quality of life and toxicities up to 12 weeks to capture weight and appetite gain and toxicities (if any) from megestrol.
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients with 18 years and above 2 Advance Stage Patients with confirmed diagnosis of ACS 3 Loss of Greater than 5 Percent pre illness of body weight in the previous 3 months 4 Life expectancy of Greater or Equal to 4 months 5 Patients receiving palliative treatment or supportive care.
排除标准
- •1 Patient with history of hypertension and diabetes mellitus 2 Mechanical obstruction to feeding 3 Pregnant women or breast-feeding women 4 History of thromboembolism and edema 5 Patients already on alternative medications that may significantly show improvement in weight gain 6 Patients refuse to consent.
结局指标
主要结局
Primary outcome
时间窗: 12weeks
1. To compare weight and appetite improvement in participants in both arms.
时间窗: 12weeks
Secondary Outcome –
时间窗: 12weeks
1. To compare quality of life at baseline and 4 weekly till the primary endpoint.
时间窗: 12weeks
2. To compare adverse events in both arms.
时间窗: 12weeks
次要结局
- Primary outcome(1. To compare weight and appetite improvement in participants in both arms.)
- Secondary Outcome –(1. To compare quality of life at baseline and 4 weekly till the primary endpoint.)
研究者
Dr Kunal Ranjan Vinayak
HBCH AND MPMMCC Varanasi