Servicio de Oncología. Hospital Infanta Sofía.
San Sebastián de los Reyes, Madrid, 28134, Spain
NCT Number: NCT05080920
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.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
San Sebastián de los Reyes, Madrid, 28134, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutritional Supplement+Usual Care
Placebo+Usual Care
Time frame: 6 months
Number of infectious events according to International Sepsis Forum Consensus
Time frame: 6 months
Number of PCR confirmed SARSCoV2 infections
Time frame: 6 months
Evolution of inflammatory markers
Time frame: 6 months
Evolution of inflammatory markers
Time frame: 6 months
Evolution of inflammatory markers
Time frame: 6 months
Evolution of inflammatory markers
Time frame: 6 months
Evolution of immune profile
Time frame: 6 months
Evolution of immune profile
Time frame: 6 months
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.
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Other
A Pilot, Randomized, Double Blind, Placebo Controlled Study to Evaluate an Immune System Modulator Nutritional Supplement for the Prevention of Infections in Cancer Patients Receiving Oncologic Treatment During the COVID-19 Pandemia.
Acronym: OnCOVInf
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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