Rosmalip® for Cancer Infections Prevention

Cancer Clinical Trial

— OnCOVInf  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080920
• Other study ID #: Rosmalip®-OnCOVInf
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Communicable Diseases
• COVID-19
• Covid19
• Infections

Intervention

Dietary Supplement:
• Rosmalip®
Nutritional Supplement+Usual Care

Other:
• Placebo
Placebo+Usual Care

Locations

Country	Name	City	State
Spain	Servicio de Oncología. Hospital Infanta Sofía.	San Sebastián de los Reyes	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares	IMDEA Food, Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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 Randomiz — View Citation

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 — View Citation

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. 2 — View Citation

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 co — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infectious events	Number of infectious events according to International Sepsis Forum Consensus	6 months
Secondary	Number of SARSCoV2 infections	Number of PCR confirmed SARSCoV2 infections	6 months
Secondary	Changes in NLR (neutrophils to lymphocytes ratio).	Evolution of inflammatory markers	6 months
Secondary	Changes in C-reactive protein	Evolution of inflammatory markers	6 months
Secondary	Changes in ferritin	Evolution of inflammatory markers	6 months
Secondary	Changes in transferrin	Evolution of inflammatory markers	6 months
Secondary	Changes in number of peripheral blood mononuclear cells	Evolution of immune profile	6 months
Secondary	Changes in number of CD4 and CD8 lymphocyte populations	Evolution of immune profile	6 months
Secondary	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

External Links

•   ALIBIRD_Therapeutic strategies for precision nutrition in cancer patients