Rosmalip® for Cancer Infections Prevention (OnCOVInf)

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.

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.

Study Overview

• Status: Completed
• Conditions: Infections; Cancer; Covid19
• Intervention / Treatment: Dietary supplement: Rosmalip®; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • San Sebastián de los Reyes, Madrid, Spain, 28134
      • Servicio de Oncología. Hospital Infanta Sofía.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infectious events	Number of infectious events according to International Sepsis Forum Consensus	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of SARSCoV2 infections	Number of PCR confirmed SARSCoV2 infections	6 months
Changes in NLR (neutrophils to lymphocytes ratio).	Evolution of inflammatory markers	6 months
Changes in C-reactive protein	Evolution of inflammatory markers	6 months
Changes in ferritin	Evolution of inflammatory markers	6 months
Changes in transferrin	Evolution of inflammatory markers	6 months
Changes in number of peripheral blood mononuclear cells	Evolution of immune profile	6 months
Changes in number of CD4 and CD8 lymphocyte populations	Evolution of immune profile	6 months
Evolution of Quality of life	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.	6 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Mouhid L, Corzo-Martinez M, Torres C, Vazquez L, Reglero G, Fornari T, Ramirez de Molina A. Improving In Vivo Efficacy of Bioactive Molecules: An Overview of Potentially Antitumor Phytochemicals and Currently Available Lipid-Based Delivery Systems. J Oncol. 2017;2017:7351976. doi: 10.1155/2017/7351976. Epub 2017 May 7.
• Gomez de Cedron M, Laparra JM, Loria-Kohen V, Molina S, Moreno-Rubio J, Montoya JJ, Torres C, Casado E, Reglero G, Ramirez de Molina A. Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers. Nutrients. 2019 Aug 24;11(9):2001. doi: 10.3390/nu11092001.
• Gonzalez-Vallinas M, Reglero G, Ramirez de Molina A. Rosemary (Rosmarinus officinalis L.) Extract as a Potential Complementary Agent in Anticancer Therapy. Nutr Cancer. 2015;67(8):1221-9. doi: 10.1080/01635581.2015.1082110. Epub 2015 Oct 9.
• Gonzalez-Vallinas M, Molina S, Vicente G, Sanchez-Martinez R, Vargas T, Garcia-Risco MR, Fornari T, Reglero G, Ramirez de Molina A. Modulation of estrogen and epidermal growth factor receptors by rosemary extract in breast cancer cells. Electrophoresis. 2014 Jun;35(11):1719-27. doi: 10.1002/elps.201400011. Epub 2014 Mar 20.
• Gonzalez-Vallinas M, Molina S, Vicente G, Zarza V, Martin-Hernandez R, Garcia-Risco MR, Fornari T, Reglero G, Ramirez de Molina A. Expression of microRNA-15b and the glycosyltransferase GCNT3 correlates with antitumor efficacy of Rosemary diterpenes in colon and pancreatic cancer. PLoS One. 2014 Jun 3;9(6):e98556. doi: 10.1371/journal.pone.0098556. eCollection 2014.
• Gonzalez-Vallinas M, Molina S, Vicente G, de la Cueva A, Vargas T, Santoyo S, Garcia-Risco MR, Fornari T, Reglero G, Ramirez de Molina A. Antitumor effect of 5-fluorouracil is enhanced by rosemary extract in both drug sensitive and resistant colon cancer cells. Pharmacol Res. 2013 Jun;72:61-8. doi: 10.1016/j.phrs.2013.03.010. Epub 2013 Apr 1.

Helpful Links

• ALIBIRD_Therapeutic strategies for precision nutrition in cancer patients

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: Rosmalip®-OnCOVInf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No