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OnCOVInf: Rosmalip® for Cancer Infections Prevention

Sponsor
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05080920
Collaborator
IMDEA Food (Other), Universidad Autonoma de Madrid (Other)
200
Enrollment
1
Location
2
Arms
26.1
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Rosmalip®
  • Other: Placebo
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official 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.
Actual Study Start Date :
Oct 28, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rosmalip®

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

Dietary Supplement: Rosmalip®
Nutritional Supplement+Usual Care
Placebo Comparator: Placebo

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

Other: Placebo
Placebo+Usual Care

Outcome Measures

Primary Outcome Measures

  1. Number of infectious events [6 months]

    Number of infectious events according to International Sepsis Forum Consensus

Secondary Outcome Measures

  1. Number of SARSCoV2 infections [6 months]

    Number of PCR confirmed SARSCoV2 infections

  2. Evolution of metabolic and immune profile [6 months]

    Evolution of levels of expression of a panel of genes related to lipid metabolism, inflammation and immune system in peripheral blood mononuclear cells and d-dimer,C-reactive protein, and NLR (neutrophils to lymphocytes ratio)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Servicio de Oncología. Hospital Infanta Sofía. San Sebastián de los Reyes Madrid Spain 28134

Sponsors and Collaborators

  • Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
  • IMDEA Food
  • Universidad Autonoma de Madrid

Investigators

  • Principal Investigator: Enrique Casado Sáenz, MD, Servicio de Oncología. Hospital Infanta Sofía
  • Study Director: Ana Ramírez de Molina, PhD, IMDEA Food
  • Study Director: Guillermo Reglero Rada, PhD, CIAL_UAM_CSIC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Enrique Casado Sáenz, Head of Oncology, Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
ClinicalTrials.gov Identifier:
NCT05080920
Other Study ID Numbers:
  • Rosmalip®-OnCOVInf
First Posted:
Oct 18, 2021
Last Update Posted:
Oct 18, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases
COVID-19

Study Results

No Results Posted as of Oct 18, 2021