Study of the Impact on Quality of Life of Nutritional Supplementation With a Food Supplement Versus Placebo in Patients With Locally Advanced/Metastatic Pancreatic Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in quality of life
研究概览
简要总结
Metastatic pancreatic cancer has a poor prognosis, with approximately one-third of patients experiencing poor quality of life at six months.
ARACOMPLEX® is a food supplement that contains maca extract, vitamin complexes and ions, and this nutritional contribution seems to favor the improvement of the patient's quality of life. To verify this statement, this experimental study is carried out in patients with locally advanced/metastatic pancreatic cancer.
详细描述
This study is composed of two phases: pilot phase and experimental phase. The pilot phase is also composed of two stages: first stage of pilot phase and second stage of pilot phase.
There are 22 patients recruited within the first stage of the pilot phase. 11 patients will be treated with ARACOMPLEX® and 11 patients will be treated with placebo. If the results are positive, a second stage of the pilot phase will take place until 43 patients are recruited in each treatment group, that is, 32 more patients in each group. The placebo group in the pilot phase is not analyzed.
In the experimental phase, a total of 234 patients are required, that is, 117 patients in each of the two study groups (ARACOMPLEX® and placebo). This phase will include the patients who participated in the pilot phase (86 patients, 43 randomized patients in each group) and 148 additional patients (74 patients in each group) up to a total of 234 patients (117 patients in each group).
If the results obtained from the analysis of the data from the first stage of the pilot phase are satisfactory, according to the protocol, the sponsor will present these results to the ethics committee, at the same time that also an addition of investigational sites, to move on to the second stage of the pilot phase. The approval or authorization of the ethics committee is required to progress to the second stage of the pilot phase.
The criteria for moving to the second stage is that more than 7 responders patients are achieved, after 6 months of treatment, out of the 11 patients in the experimental group. The responder patient is the one who meets an improvement in quality of life (difference of at least 10 points of quality improvement on the EORTC QLQ-C30 scale) between baseline and final time.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with locally advanced or metastatic pancreatic cancer without previous chemotherapy treatment.
- •Patients for whom chemotherapy treatment has been indicated.
- •Adequate bone marrow function (neutrophils ≥1500 mm3, platelets ≥100,000 mm3), adequate liver function (bilirubin ≤1.5 times the upper limit of the normal range)
- •Adequate renal function (glomerular filtration rate greater than or equal to 90 ml/min/1.73).
- •ECOG functional stage 0-1 (Karnofsky ≥ 80).
- •Patients must agree to carry out study visits and procedures with precise instructions.
排除标准
- •Age ≥76 years.
- •Endocrine or acinar pancreatic cancer.
- •Serious systemic diseases such as: sepsis, heart failure, severe COPD, liver failure and chronic kidney disease.
- •Prior radiation to areas of measurable disease.
- •Chronic diarrhea.
- •Active infection.
- •Significant medical history of heart disease.
- •Pregnancy or lactation.
- •Impossibility of the patient, due to medical condition, to follow the study.
研究组 & 干预措施
Control arm
Placebo. 2 tablets per day, during 6 months.
干预措施: placebo (Dietary Supplement)
Experimental arm
ARACOMPLEX® (food supplement). 2 tablets per day, during 6 months.
干预措施: ARACOMPLEX® (Dietary Supplement)
结局指标
主要结局
Change in quality of life
时间窗: 6 months
To assess the degradation of quality of life at 6 months using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale in patients with locally advanced/metastatic pancreatic cancer receiving chemotherapy and supplementation with ARACOMPLEX® (PILOT PHASE) and compared with patients that are treated with chemotherapy and placebo (EXPERIMENTAL PHASE). The EORTC QLQ-C30 includes the "Global Health Status/Quality of life" scales, which are composed by items 29 and 30, and they are scored from 0 (worse) to 100 (better).
次要结局
- Compliance treatment(1 month, 3 months and 6 months.)
- Nutritional status assessment(Baseline, 1 month, 3 months and 6 months.)
- Tumor response assessment(Assessment at the end of the third and sixth chemotherapy cycles, as per normal clinical practice.)
- Adverse events due to chemotherapy(1 month, 3 months and 6 months.)
- Functional status assessment(Baseline, 1 month, 3 months and 6 months.)