Trials / Completed
CompletedNCT05080920
Rosmalip® for Cancer Infections Prevention
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Rosmalip® | Nutritional Supplement+Usual Care |
| OTHER | Placebo | Placebo+Usual Care |
Timeline
- Start date
- 2020-10-28
- Primary completion
- 2022-09-30
- Completion
- 2022-12-31
- First posted
- 2021-10-18
- Last updated
- 2023-09-21
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05080920. Inclusion in this directory is not an endorsement.