Rosmalip® for Cancer Infections Prevention (OnCOVInf)

Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares

Status: Completed

Conditions: Covid19; Cancer; Infections

Treatments: Other: Placebo; Dietary Supplement: Rosmalip®

Study type: Interventional

Funder types: Other

Identifiers

NCT05080920

Rosmalip®-OnCOVInf

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 2 patient groups, including a placebo group

Rosmalip®

Experimental group

Description:

Participants receive Rosmalip® (diterpene phenols 11,25 mg) 1 capsule orally once daily for 16 weeks

Treatment:

Dietary Supplement: Rosmalip®

Placebo

Placebo Comparator group

Description:

Participants receive Placebo 1 capsule matching Rosmalip® orally once daily for 16 weeks

Treatment:

Other: Placebo