NCT02106871撤回1 期
Phase I Assessment of NO Mediated Signaling in Cancer Cachexia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Lean Body Mass
研究概览
简要总结
Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.
详细描述
This is a double-blinded, placebo-controlled trial in men and women, 40-75 years old, diagnosed with pancreatic or cholangiocarcinoma cancer. Patients will receive placebo or sildenafil daily for 4 weeks during their initial chemotherapy cycle.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, aged 40-75 years.
- •Diagnosed with Stage III or IV pancreatic or cholangiocarcinoma receiving the following therapy:
- •Neoadjuvant chemotherapy
- •Surgical resection followed by chemotherapy.
- •Able to comprehend risks and sign a consent form.
- •Performance Status of 0-2.
排除标准
- •Significant renal or heart disease or any acute metabolic disease.
- •Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
- •Diabetes mellitus or other untreated endocrine disease.
- •Recent (within 3 months) treatment with anabolic steroids.
- •Ongoing anticoagulant therapy.
- •Androgen secreting tumors of the ovary and adrenal or any ovarian tumor (e.g., Sertoli-Leydig).
- •Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
- •Non-classical adrenal hyperplasia.
- •Cushing's syndrome.
- •Glucocorticoid resistance.
- •Hyperprolactinoma, hypothyroidism.
- •Use of nitrates.
- •Use of alpha blockers.
- •Use of protease inhibitors.
- •Use of cytochrome p450 inhibitors.
- •Systolic blood pressure <100 or >150, diastolic blood pressure <60 or >
- •This range is smaller than the acceptable range stated in the prescribing information for sildenafil (>90/50 and <170/110).
- •Peripheral vascular disease.
- •Use of a phosphodiesterase 5 inhibitor.
- •Any other circumstance deemed exclusionary by the PI or study physician.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo daily for 4 weeks
干预措施: Sildenafil (Drug)
Sildenafil
Active Comparator
50mg sildenafil daily for 4 weeks
干预措施: Sildenafil (Drug)
结局指标
主要结局
Lean Body Mass
时间窗: 4 weeks
Lean body mass will be measured by DEXA scan
Skeletal Muscle Fatigue
时间窗: 4 weeks
Skeletal muscle fatigue will be measured by leg dynamometer.
次要结局
未报告次要终点
研究者
研究点 (1)
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