Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 12
- 主要终点
- Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
研究概览
简要总结
Ovarian cancer patients are often at risk of malnutrition because of weight loss, lack of appetite and reduced food intake. Being malnourished can contribute to the incidence and severity of cancer treatment side effects and increase the risk of infection. Currently patients with advanced ovarian cancer do not receive early nutrition using a feeding tube.
The purpose of this study is to compare enteral nutrition along with standard post-surgery care against current standard post-operative care alone. This study will see if early nutrition using a feeding tube has an impact on length of hospital admission, recovery from surgery, complications from surgery, nutritional status and ultimately a reduction in treatment costs in people with Advanced Epithelial Ovarian Cancer (EOC). Primary Peritoneal Cancer (PPC) or Fallopian Tube Cancer. Nutritional support has been shown to ;
- Prevent and treat under-nutrition,
- Enhance anti-tumour treatment effects,
- Reduce adverse effects of anti-tumour therapies,
- Improve quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients requiring planned primary surgery for suspected or histologically proven advanced ovarian, primary peritoneal cancer or fallopian tube cancer.
- •Signs of moderate or severe malnutrition - Patient Generated Subjective Global Assessment (PG-SGA) Category B or C and/or a total numerical score of 4 or more in the PG-SGA
- •Medically fit for primary surgery
- •Signed written informed consent
- •Females aged 18 years or older
排除标准
- •Other histological type than ovarian cancer, peritoneal cancer or fallopian tube cancer
- •Recurrent ovarian cancer, peritoneal or fallopian tube cancer
- •Pre-existing contraindications to enteral nutrition such as ileus, gastrointestinal ischemia, bilious or persistent vomiting, or mechanical obstruction
- •Positive urine pregnancy test
- •Unfit for surgery; serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- •Participation in other clinical trials that may have an impact on the outcomes of this trial.
结局指标
主要结局
Cost outcomes as represented by length of stay and cost effectiveness of enteral feeding / Quality of life
时间窗: End of study
Compare treatment costs and cost effectiveness between early enteral feeding with standard post-operative care versus current standard ost-operative care for advanced epithelial ovarian cancer. Compare quality of life after surgery between women who receive early enteral feeding along with standard post-operative care versus those who receive current standard post-operative care for advanced epithelial ovarian cancer
次要结局
- length of stay(Until discharge from hospital)
- Need for inotropic medications and intravenous treatment requirements(Until discharge from hospital)
- Nutritional status 6 weeks after surgery(6 weeks after surgery)
- Treatment related adverse events(End of study)
- Delay and dose reductions of chemotherapy / quality of life during chemotherapy(End of study)