Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients
NCT03469063 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2018-06-14
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 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.
Conditions
- Quality of Life
- Infection
- Drug Toxicity
Interventions
- DIETARY_SUPPLEMENT
-
AferBio
Patients will use the product (AferBio/Placebo) once a day for seven days, and then twice a day, continuously (for a total of three months of use).
Sponsors & Collaborators
-
Barretos Cancer Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-28
- Primary Completion
- 2020-02-28
- Completion
- 2020-06-30
Countries
- Brazil
Study Locations
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