Status:
UNKNOWN
Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients
Lead Sponsor:
Barretos Cancer Hospital
Conditions:
Quality of Life
Infection
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 ferme...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03469063
Start Date
June 28 2018
End Date
June 30 2020
Last Update
June 14 2018
Active Locations (1)
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1
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784400