Evaluation of the Effect of Ocoxin-Viusid® Nutritional Supplement in the Life Quality in Patients Diagnosed With Advanced Pancreatic Adenocarcinoma. Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Quality of Life: EORTC QLQ-C30
研究概览
简要总结
The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.
详细描述
To assess the effect of Ocoxin-Viusid® on the quality of life of patients with advanced pancreatic adenocarcinoma.
To evaluate the effect of Ocoxin-Viusid® on the quality of life of patients. To evaluate the influence of Ocoxin-Viusid® on tolerance to onco-specific therapy.
Identify the changes that occur in the nutritional status of patients receiving the supplement.
To evaluate the toxicity of Ocoxin-Viusid® in combination with chemotherapy in patients with advanced pancreatic adenocarcinoma.
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
- •Patients of any sex, resident in Cuba, with an age greater than or equal to 18 years.
- •Patients that meet the diagnostic criteria.
- •Patients with general health according to Karnofsky ≥70 %.
- •Life expectancy greater than or equal to 3 months.
- •Patients eligible to receive chemotherapy.
- •Patients who have signed the informed consent.
- •Patients who have laboratory values in parameters that do not contraindicate the administration of chemotherapy:
- •Hemoglobin ≥ 90 g / l.
- •Total Leukocyte Count ≥ 3.0 x 109 / L.
- •Absolute Neutrophil Count ≥1.5 x 109 / L.
- •Platelet count ≥100 x 109 / L.
- •Total bilirubin values ≤ 1.5 times the upper limit of the normal range established in the institution.
- •TGO and TGP values ≤2.5 times the upper limit of the normal interval established in the institution.
- •Creatinine values within the normal limits of the institution.
排除标准
- •Pregnant or lactating patients.
- •Patients with known hypersensitivity to any of the active ingredients of the chemotherapy used
- •Patients who are receiving another product under investigation.
- •Patients with decompensated intercurrent diseases, including: hypertension, diabetes mellitus, ischemic heart disease, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage or any other special condition that at the discretion of the doctor puts their health at risk and his life during the study or his participation in the trial.
- •Patients with brain metastases.
- •Patients with mental disorders that may limit adherence to the requirements of the clinical trial and may hinder the collection of information, treatment or follow-up.
- •It is planned to include a total of 30 patients in the study, taking into account 10% of losses.
结局指标
主要结局
Quality of Life: EORTC QLQ-C30
时间窗: 12 months
Life quality measurement through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (ORTC QLQ-C30): an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. It's composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
次要结局
- Compliance with the treatment with chemotherapy (CT) and Immunotherapy (IT) test(12 months)
- Hematology test(12 months)
- Blood Chemistry test(12 months)
- Nutritional Status of the patient during Chemotherapy(12 months)
- Adverse Events-AE during Chemotherapy Test(12 months)