This study is designed to assess the safety and efficacy of Rosmalip® nutritional supplement compared to placebo in subjects with solid cancer for the prevention of infections including COVID-19.
Cancer patients undergoing oncologic treatments frequently have comorbidities and suffer immunosuppresion, toxicities and exposure to nosocomial pathogens. As a result, they are at increased risk of infections, including COVID-19. It is of utmost importance to find therapies that can prevent infections with as less toxicity as possible. Rosmalip® is a nutritional supplement developed as a molecular nutrition, composed of a rosemary supercritical extract at concentrations approved by EFSA -with in vitro and in vivo antitumor effects that are independent of its antioxidant and anti-inflammatory properties- in a lipidic vehicle that has shown in preclinical and clinical studies to potentiate innate immunity without apparent toxicity. Being a product of easy synthesis its effects on immunity, inflammation and cancer, could be of interest to prevent and ameliorate infections, including COVID-19. In this pilot study it is hypothesized that Rosmalip® could help to prevent or ameliorate infections, including COVID-19, in oncologic patients under active treatment. Secondarily, it is also hypothesized to have metabolic beneficial effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
109
Servicio de Oncología. Hospital Infanta Sofía.
San Sebastián de los Reyes, Madrid, Spain
Number of infectious events
Number of infectious events according to International Sepsis Forum Consensus
Time frame: 6 months
Number of SARSCoV2 infections
Number of PCR confirmed SARSCoV2 infections
Time frame: 6 months
Changes in NLR (neutrophils to lymphocytes ratio).
Evolution of inflammatory markers
Time frame: 6 months
Changes in C-reactive protein
Evolution of inflammatory markers
Time frame: 6 months
Changes in ferritin
Evolution of inflammatory markers
Time frame: 6 months
Changes in transferrin
Evolution of inflammatory markers
Time frame: 6 months
Changes in number of peripheral blood mononuclear cells
Evolution of immune profile
Time frame: 6 months
Changes in number of CD4 and CD8 lymphocyte populations
Evolution of immune profile
Time frame: 6 months
Evolution of Quality of life
Changes is quality of life according to the SF-36 (Short Form Health Survey) questionnaire. The score values goes from 0 to 100 and higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
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Time frame: 6 months