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OpenTrials
Completed

NCT Number: NCT05080920

Rosmalip® for Cancer Infections Prevention

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Oncología. Hospital Infanta Sofía.

San Sebastián de los Reyes, Madrid, 28134, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosmalip®

Dietary Supplement

Nutritional Supplement+Usual Care

Placebo

Other

Placebo+Usual Care

Primary outcomes

  1. Number of infectious events

    Time frame: 6 months

    Number of infectious events according to International Sepsis Forum Consensus

Secondary outcomes

  1. Number of SARSCoV2 infections

    Time frame: 6 months

    Number of PCR confirmed SARSCoV2 infections

  2. Changes in NLR (neutrophils to lymphocytes ratio).

    Time frame: 6 months

    Evolution of inflammatory markers

  3. Changes in C-reactive protein

    Time frame: 6 months

    Evolution of inflammatory markers

  4. Changes in ferritin

    Time frame: 6 months

    Evolution of inflammatory markers

  5. Changes in transferrin

    Time frame: 6 months

    Evolution of inflammatory markers

  6. Changes in number of peripheral blood mononuclear cells

    Time frame: 6 months

    Evolution of immune profile

  7. Changes in number of CD4 and CD8 lymphocyte populations

    Time frame: 6 months

    Evolution of immune profile

  8. Evolution of Quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares

Other

Collaborators

  • IMDEA Food
  • Universidad Autonoma de Madrid

Registry information

Official study title

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.

Acronym: OnCOVInf

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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