Rosmalip® for Cancer Infections Prevention

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Infections, Covid19, Cancer

Intervention / Treatment
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* Dietary Supplement: Rosmalip®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosmalip®<br>Participants receive Rosmalip® (diterpene phenols 11,25 mg) 1 capsule orally once daily for 16 weeks | Dietary Supplement: Rosmalip®<br>* Nutritional Supplement+Usual Care<br>|
| Placebo Comparator: Placebo<br>Participants receive Placebo 1 capsule matching Rosmalip® orally once daily for 16 weeks | Other: Placebo<br>* Placebo+Usual Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infectious events | Number of infectious events according to International Sepsis Forum Consensus | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of SARSCoV2 infections | Number of PCR confirmed SARSCoV2 infections | 6 months | 
| Changes in NLR (neutrophils to lymphocytes ratio). | Evolution of inflammatory markers | 6 months | 
| Changes in C-reactive protein | Evolution of inflammatory markers | 6 months | 
| Changes in ferritin | Evolution of inflammatory markers | 6 months | 
| Changes in transferrin | Evolution of inflammatory markers | 6 months | 
| Changes in number of peripheral blood mononuclear cells | Evolution of immune profile | 6 months | 
| Changes in number of CD4 and CD8 lymphocyte populations | Evolution of immune profile | 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. | 6 months |