Cancer, Covid19, Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTRosmalip®
Nutritional Supplement+Usual Care
OTHERPlacebo
Placebo+Usual Care
Sponsors
IMDEA Food
Universidad Autonoma de Madrid
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a solid cancer under active Anticancer Treatment (including Chemotherapy, Immunotherapy, Hormone Therapy, Targeted Therapy) * Informed consent signature
Exclusion criteria
* Allergies to fish * Vitamin, Antioxidants consumers and who would no accept to stop taking them 1 week before and during the study * Disphagia * Bilirrubin higher than 1.5 Upper Normal Limit (UNL)/ Creatinin \> 1.5 UNL * Severe organic dysfunction * Cardiac dysfunction * Cholangitis/ Biliary tract obstruction * Immunodeficiency or Immflamatory disease (HIV, Inflammatory Bowel Disease, Collagenosis) * Dementia or Psychiatric severe disease * Pregnancy or Breastfeeding * Previous diseases that interfere lipid carrier absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of infectious events | 6 months | Number of infectious events according to International Sepsis Forum Consensus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NLR (neutrophils to lymphocytes ratio). | 6 months | Evolution of inflammatory markers |
| Changes in C-reactive protein | 6 months | Evolution of inflammatory markers |
| Changes in ferritin | 6 months | Evolution of inflammatory markers |
| Number of SARSCoV2 infections | 6 months | Number of PCR confirmed SARSCoV2 infections |
| Changes in number of peripheral blood mononuclear cells | 6 months | Evolution of immune profile |
| Changes in number of CD4 and CD8 lymphocyte populations | 6 months | Evolution of immune profile |
| Evolution of Quality of life | 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. |
| Changes in transferrin | 6 months | Evolution of inflammatory markers |
Countries
Spain
Outcome results
None listed