Rosmalip® for Cancer Infections Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Infections Covid19 Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Rosmalip®

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

Group Type EXPERIMENTAL

Rosmalip®

Intervention Type DIETARY_SUPPLEMENT

Nutritional Supplement+Usual Care

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo+Usual Care

Interventions

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Placebo

Placebo+Usual Care

Intervention Type OTHER

Rosmalip®

Nutritional Supplement+Usual Care

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No