Efficacy of Oncoxin-Viusin® Nutritional Supplement Related With the Onco-specific Treatments in Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
A not randomized clinical survey was done in 25 pacients with histological diagnosis confirmed of a prostatic adenocarcinoma and hardy in hormonotherapy at the Calixto Garcia Hospital in Habana (2016-2018).
Researches had as identifying goal the efecctiveness study of Oncoxin-Viusid® nutritional supplement as a support to convencional treatment. The patient were treated with habitual doses of Docetacel and 75 mg per day of supplement during and fiften day after the quimiotherapy. The rest of numbers and severety of adverse reactions were determined as well as its influences on life quality when this co-therapy is performed, the evaluation of progresion spare survival and the porcentage of recurrences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Masculine >18 years-old patients
- •Performans status: Karnofsky ≥ 70 or (ECOG <2)
- •Hormonal treatment alternatives 6 or 8 weeks before the inclusion ,with resistence to hormonal treatments
- •Normal laboratory tests to onco-specific treatments.
- •Ecocardiogram with a eyección fraction > 60 %, in patients with history of cardiovascular deseases.
- •Patients with life expectative more than 6 months.
排除标准
- •Patients who are receiving another onco-specific product in research.
- •Patients with known hypersensitivity to anthracyclines and / or mitoxantrone
- •Decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health and life at risk during the study or your participation in the trial.
- •Patients with cerebral metastases.
- •Patients with HIV.
研究组 & 干预措施
Oncoxin-Viusid
干预措施: Oncoxin-Viusid (Dietary Supplement)
结局指标
主要结局
Quality of Life
时间窗: 12 months
General quality of life (EORTC QLQ C30 questionnaire and specific for prostate cancer EORTC QLQ - PR25)
Adverse events
时间窗: 12 months
Toxicity (hematological, hemochemistry, clinical response) stablished by WHO
次要结局
- Overal survival(12 months)
- Overal recurrences(12 months)