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Impact of AferBio® on quality of life and chemotherapy toxicity in advanced lung cancer patients (AFERBIO study): protocol study for a phase II randomized controlled trial.

ABSTRACT: BACKGROUND: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). 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/DESIGN:A 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. DISCUSSION: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. 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 REGISTRATION:This 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.

SUBMITTER: D'Almeida Preto D

PROVIDER: S-EPMC6485167 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Impact of AferBio® on quality of life and chemotherapy toxicity in advanced lung cancer patients (AFERBIO study): protocol study for a phase II randomized controlled trial.

D'Almeida Preto Daniel D Baston Mariana Toledo MT Geraige Camilla Centurion CC Augusto Sarah Bertazzi SB de Oliveira Marco Antonio MA Mamere Augusto Elias AE Pinto Gustavo Dix Junqueira GDJ Dias Josiane Mourão JM De Marchi Pedro Rafael Martins PRM Paiva Bianca Sakamoto Ribeiro BSR Paiva Carlos Eduardo CE

BMC cancer 20190425 1

<h4>Background</h4>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). 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 AferBi ...[more]

PMID: 31023257

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Project description:IntroductionThe NICHE trial showed remarkable results of neoadjuvant immunotherapy in colorectal cancer patients with mismatch repair (MMR) deficiency (dMMR). However, rectal cancer patients with dMMR accounted for only 10% of case. The therapeutic effect is unsatisfactory in MMR-proficient patients. Oxaliplatin has been demonstrated to induce immunogenic cell death (ICD), which may improve the therapeutic effect of programmed cell death 1 blockade; however, a maximum tolerated dose is required to induce ICD. Arterial embolisation chemotherapy provides drugs locally and can easily reach the maximum tolerated dose, which could be a significant method for delivering chemotherapeutic agents. Therefore, we designed a multicenter, prospective, single-arm, phase II study.Methods and analysisFirst, recruited patients will receive neoadjuvant arterial embolisation chemotherapy (NAEC) with oxaliplatin 85 mg/m2 and 3 mg/m2. After 2 days, three cycles of immunotherapy with intravenous tislelizumab (200 mg/body, day 1) will be initiated at an interval of 3 weeks. From the second cycle of immunotherapy, the XELOX regimen will be added. 3 weeks after neoadjuvant therapy finished, the operation will be initiated. Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer (NECI) Study combined arterial embolisation chemotherapy, immunotherapy and systemic chemotherapy. Based on this combination therapy, the maximum tolerated dose could easily be reached, and ICD could be induced by oxaliplatin easily. To our knowledge, the NECI Study is the first multicenter, prospective, single-arm, phase II clinical trial to assess the efficacy and safety of NAEC combined with tislelizumab and systemic chemotherapy in locally advanced rectal cancer. This study is expected to provide a new neoadjuvant therapeutic regimen for locally advanced rectal cancer.Ethics and disseminationThe Human Research Ethics Committee of the Fourth Affiliated Hospital of Zhejiang University School of Medicine approved this study protocol. The results will be published in peer-reviewed journals and presented at appropriate conferences.Trial registration numberNCT05420584.

Project description:BACKGROUND:Clinical data indicates that delivery of larger daily doses of radiation may improve the therapeutic ratio for prostate cancer compared to conventional fractionation. A phase II study of stereotactic body radiotherapy with real-time motion management and daily plan re-optimization for low to intermediate risk prostate cancer was undertaken to evaluate this hypothesis. This report details the toxicity and quality of life following treatment. METHODS:From 2009 to 2013, 60 patients with T1-T2c prostate cancer with a Gleason score of 6 and PSA???15 or Gleason score of 7 and PSA???10 were enrolled. Patients with nodal metastases, an American Urological Association symptom score?>?18, or gland size?>?100 g were not eligible. Patients were treated to 37 Gy in 5 fractions. Early and late genitourinary and gastrointestinal toxicity were graded based on NCI CTCAE v4.0 and quality of life was assessed by the American Urological Association symptom score, International Index of Erectile Function, and Expanded Prostate cancer Index Composite Short Form up to 36 months after treatment. RESULTS:After a median follow-up of 27.6 months, no grade 3 or greater genitourinary toxicity was observed. Four patients (6.7%) reported a late grade 2 genitourinary toxicity. One patient (1.7%) reported a late grade 3 gastrointestinal toxicity. Five patients (8.3%) developed a late grade 2 gastrointestinal toxicity. The median American Urological Association symptom score increased from 4.5 prior to treatment to 11 while on treatment (p?<?0.01), but was 5 at 36 months post-treatment (p?=?0.65). Median International Index of Erectile Function scores decreased from 19 to 17 over the course of follow-up (p?<?0.01). Only median scores within the Expanded Prostate Cancer Index Composite Short Form sexual domain were significantly decreased at 36 months post-treatment (67.9 vs 45.2, p?=?0.02). There was no significant difference in median score within the urinary, bowel, or hormonal domains at 36 months of follow-up. CONCLUSIONS:Stereotactic body radiotherapy for low to intermediate risk prostate cancer is well tolerated with limited toxicity or decrease in quality of life. Longer follow-up is necessary to assess the efficacy of treatment. TRIAL REGISTRATION:Clinicaltrials.gov NCT00941915 Registered 17 June 2009.

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Impact of AferBio® on quality of life and chemotherapy toxicity in advanced lung cancer patients (AFERBIO study): protocol study for a phase II randomized controlled trial.

Publications

Impact of AferBio® on quality of life and chemotherapy toxicity in advanced lung cancer patients (AFERBIO study): protocol study for a phase II randomized controlled trial.

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