Abstract
BackgroundLung cancer patients undergoing palliative chemotherapy exhibit many symptoms related to the disease, such as adverse events and infectious complications during treatment, which impacts directly their health-related quality of life (HRQOL). Nutritional status is a relevant aspect among advanced cancer patients under palliative care and food supplementation has the potential to reduce treatment-related adverse effects and improve the nutritional status. The product named AferBio® is a fermented supplement that has been described as able to provide some benefits, including the capacity to potentiate the effects of anticancer drugs, by promoting the reduction of side effects and ultimately improving HRQOL.Methods/designA Phase II double-blind placebo-controlled randomized clinical trial to assess the use of food supplementation with AferBio® in Stage IIIB or IV non-small cell lung cancer (NSCLC) patients beginning a second-line palliative mono-chemotherapy. The primary goal is to compare HRQOL scores between the arms of the study over time. The ten first patients included in the present study will undergo an AferBio®toxicity-testing (non-randomized phase). If no significant toxicity is found, the study will move on to the randomized phase. All patients will be randomized in blocks at a 1:1 ratio using the online tool REDCap. ECOG-PS (0–1 versus 2) criteria will be used for stratification. All patients included in the trial will be evaluated at baseline and at each chemotherapy cycle. Each evaluation will include the following: HRQOL (EORTC QLQ-C30, LC13 and IQualiV-Lung), ECOG-PS, anthropometric measurements, clinical and laboratory toxicity assessment and response evaluation.DiscussionDuring palliative systemic therapy in advanced cancer patients, one of the main goals is the improvement and maintenance of HRQOL, which can be negatively affected by cancer symptoms, cancer- or treatment-related psychosocial difficulties, and chemotherapy toxicity. Thus, much research has been dedicated to the development of new and more effective and/or less toxic cancer therapies. The present study is justified by the testing of a novel food supplement that may reduce some toxicities, thus, having a potential positive impact on the HRQOL of lung cancer patients. The product in question (AferBio®) is already available for sale in Brazil, but has not yet been fully tested in cancer patients.Trial registrationThis Trial was registered on March 19, 2018 with ClinicalTrials.gov, NCT03469063. Protocol version: 2.0 from March 26, 2018. Trial status: Patient enrollment in the study began in April, 2018.
Highlights
Lung cancer patients undergoing palliative chemotherapy exhibit many symptoms related to the disease, such as adverse events and infectious complications during treatment, which impacts directly their health-related quality of life (HRQOL)
During palliative systemic therapy in advanced cancer patients, one of the main goals is the improvement and maintenance of HRQOL, which can be negatively affected by cancer symptoms, cancer- or treatment-related psychosocial difficulties, and chemotherapy toxicity
The present study is justified by the testing of a novel food supplement that may reduce some toxicities, having a potential positive impact on the HRQOL of lung cancer patients
Summary
Studies have been conducted to assess the likely effects of AferBio® in animals and humans. Patients with chronic kidney disease on hemodialysis who suffered from constipation due to the side effects of a component of their drug therapy commonly prescribed by nephrologists, i.e., calcium carbonate, received supplementation with AferBio® to assess the impact of this high-fiber product on bowel transit. Ethics approval and consent to participate The present study was developed according to the norms of Resolution CNS 466/12 (Brazilian National Health Council) and was approved by the Research Ethics Committee of the Barretos Cancer Hospital (n° 2.395.325). This trial is registered with ClinicalTrials.gov, NCT03469063. Author details 1Health-Related Quality of Life Research Group (GPQual), Learning and Research Institute, Barretos Cancer Hospital, Barretos, São Paulo, Brazil. Author details 1Health-Related Quality of Life Research Group (GPQual), Learning and Research Institute, Barretos Cancer Hospital, Barretos, São Paulo, Brazil. 2Department of Clinical Oncology, Barretos Cancer Hospital, Rua Antenor Duarte Vilella, 1331, Bairro Dr Paulo Prata, Barretos, SP, Brazil. 3Faculty of Nutrition, Faculdade Barretos, Barretos, São Paulo, Brazil. 4Center for Epidemiology and Biostatistics, Barretos Cancer Hospital, Barretos, São Paulo, Brazil. 5Radiology Department, Barretos Cancer Hospital, Barretos, São Paulo, Brazil
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