NCT03469063Unknown不适用
Randomized Clinical Trial to Assess the Impact of AferBio® on Quality of Life and Toxicity to Chemotherapy in Patients With NSCLC Beginning Second-line Palliative Mono-chemotherapy
Barretos Cancer Hospital2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2018年6月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Health-related QOL scores over time.
研究概览
简要总结
The AFERBIO study will evaluates safety and potential benefit of AferBio® in patients with non-small cell lung cancer undergoing at least a second-line palliative monochemotherapy. AferBio® is a fermented supplement in powder form obtained through biotechnological processes developed in Brazil. In this double-blind placebo-controlled randomized clinical trial, participants starting a new palliative regimen will be allocated to AferBio® or placebo. The primary aim will be to compare health-related QOL scores among the arms of the study over 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
- Triple (Participant, Care Provider, 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
- •Age above or equal to 18 years, and below 75 years;
- •Diagnosis of metastatic or recurrent NSCLC, beginning second-line palliative mono-chemotherapy treatment;
- •Functional capacity (ECOG-PS) grade 0 - 2;
- •Adequate hematological, kidney and liver function, as follows:
- •Total neutrophil count ≥ 1500/μL
- •Platelet count ≥ 100.000/μL
- •Hemoglobin ≥ 9 g/dL
- •Serum bilirubin ≤ 1.5 × upper limit of normal (ULN)
- •Patients with confirmed Gilbert's syndrome and serum bilirubin ≤ 3 × ULN
- •Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min based on the Cockcroft-Gault equation:
- •(140 - age) × (weight in Kkg) × (0.85) 72 × (serum creatinine in mg/dL)
- •Absence of any emotional, family-related, sociological, or geographic condition that can potentially hamper adherence to the study protocol and the follow-up schedule;
- •Capacity and willingness to adhere to the study visits and tests, and to adhere to the protocol, according to the researcher's evaluation.
排除标准
- •Tube feeding, gastrostomy- or jejunostomy;
- •Uncontrollable vomiting;
- •Sexually active women of reproductive age, except for those who underwent surgical sterilization (e. g., tubal ligation);
- •Intestinal obstruction or sub-obstruction;
- •Known allergy to any of the components of the investigational product;
- •Malabsorption syndrome or other condition that could interfere with enteric absorption;
- •History of inflammation of the small or large intestine, previous or currently active (such as Crohn's disease or ulcerative colitis);
- •Chronic diarrhea of any cause;
- •Diagnosis of any chronic disease that, in the researcher's opinion, will interfere with the participation in the study;
- •Known diagnosis of HIV -infection;
- •Diagnosis of any chronic disease that changes the immune system and significantly increases the risk of infection;
- •The need to use G-CSF already in the first chemotherapy cycle;
- •Severe neuropsychiatric disease that prevents the patient from completing the study questionnaires, determined at the researcher's discretion.
研究组 & 干预措施
AferBio
Experimental
Daily oral AferBio (20 g/day, in sachets)
干预措施: AferBio (Dietary Supplement)
Placebo
Placebo Comparator
Daily oral placebo (20 g/day, in sachets)
干预措施: AferBio (Dietary Supplement)
结局指标
主要结局
Health-related QOL scores over time.
时间窗: Over time (during 90 days)
To compare health-related QOL scores among the arms of the study over time.
次要结局
- Dose intensity(3 months)
- Toxicity(3 months)
- 20% reduction in HRQOL(Along the study (3 months))
- Treatment delays(3 months)
- Dose-reduction rates(3 months)
- Infections(3 months)
- Antineoplastic response rates(3 months)
- Incidence of febrile neutropenia(3 months)
- Nutritional status(Along the study (3 months))
- Progression-free survival(3 months)
- Hospitalizations(3 months)
- ECOG-PS worsening-free survival(Along the study (3 months))
- Adherence to AferBio®(3 months)
- Use of anti-microbials(3 months)
- Use of G-CSF(3 months)
研究者
研究点 (2)
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