A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Proportion of Patients Who Maintain Weight or Experience Weight Gain
研究概览
简要总结
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.
详细描述
PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.
SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas)
- •≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy
- •Negative pregnancy test done =< 7 days prior to registration for women of childbearing potential only
排除标准
- •Receiving tube feedings or parenteral nutrition
- •Evidence of ascites
- •Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
- •Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (> 5 episodes/week)
- •History of unresectable brain tumor or cancer metastatic to the brain
- •History of thromboembolic disease
- •Insulin-requiring diabetes
- •Congestive heart failure and/or uncontrolled hypertension
- •Anticoagulation
- •Previous history of thrombosis (personal and immediate family)
- •Concurrent corticosteroid therapy (except as an antiemetic)
研究组 & 干预措施
Arm A
Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
干预措施: megestrol acetate (Drug)
Arm B
Patients have clinical observation for weight loss and gain for 4 weeks.
干预措施: clinical observation (Other)
结局指标
主要结局
Proportion of Patients Who Maintain Weight or Experience Weight Gain
时间窗: 4 weeks
A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.
次要结局
- Weight Maintenance Over Time(4 weeks)
- BMI Trends(4 weeks)
- Caloric Intake(4 weeks)
- Toxicity Profile(4 weeks)