Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Quality of life (QLQ-C30)
研究概览
简要总结
RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment.
PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.
详细描述
OBJECTIVES:
Primary
- Measure quality of life (QLQ-C30) at week 18 in patients with metastatic gynecological cancer receiving systematic nutritional supplements during first-line chemotherapy.
Secondary
- Study the maintenance or improvement of intake and nutritional status.
- Study the quality of life during chemotherapy.
- Evaluate tolerance and compliance to treatment with nutritional supplements.
- Evaluate the feasibility of and the tolerance to chemotherapy.
- Measure the overall survival over 18 weeks.
- Analyze the cost-effectiveness of different strategies of nutritional care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed gynecological cancer
- •Currently receiving first-line chemotherapy for metastatic disease
- •PATIENT CHARACTERISTICS:
- •WHO performance status (PS) 0-2 or Karnofsky PS 70-100%
- •Not pregnant or nursing
- •Intake < 75% of theoretical need
- •Weight loss ≥ 5% within the past 6 months
- •No patients with dementia or altered mental status
- •No psychological, familial, social, or geographic situations that preclude clinical follow up
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Arm III
Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks with additional biweekly assessments completed at home by a service provider.
干预措施: standard follow-up care (Procedure)
Arm I
Patients are monitored via standard follow-up assessments every 3 weeks.
干预措施: standard follow-up care (Procedure)
Arm II
Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
干预措施: therapeutic nutritional supplementation (Dietary Supplement)
Arm II
Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
干预措施: standard follow-up care (Procedure)
Arm III
Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks with additional biweekly assessments completed at home by a service provider.
干预措施: therapeutic nutritional supplementation (Dietary Supplement)
结局指标
主要结局
Quality of life (QLQ-C30)
次要结局
未报告次要终点