Clinical trial NCT05080920: Rosmalip® for Cancer Infections 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Covid19
Cancer
Lead sponsor: Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Sponsor class: OTHER
Collaborators: name: IMDEA Food
name: Universidad Autonoma de Madrid
First posted: 2021-10-18
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of infectious events
timeFrame: 6 months
Secondary outcomes:
measure: Number of SARSCoV2 infections
timeFrame: 6 months
measure: Changes in NLR (neutrophils to lymphocytes ratio).
timeFrame: 6 months
measure: Changes in C-reactive protein
timeFrame: 6 months
measure: Changes in ferritin
timeFrame: 6 months
measure: Changes in transferrin
timeFrame: 6 months
measure: Changes in number of peripheral blood mononuclear cells
timeFrame: 6 months
measure: Changes in number of CD4 and CD8 lymphocyte populations
timeFrame: 6 months
measure: Evolution of Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: San Sebastián de los Reyes
country: Spain
facility: Servicio de Oncología. Hospital Infanta Sofía.
state: Madrid
Study officials:
affiliation: Servicio de Oncología. Hospital Infanta Sofía
name: Enrique Casado Sáenz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IMDEA Food
name: Ana Ramírez de Molina, PhD
role: STUDY_DIRECTOR
affiliation: CIAL_UAM_CSIC
name: Guillermo Reglero Rada, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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. 2014 Jun;35(11):1719-27. doi: 10.1002/elps.201400011. Epub 2014 Mar 20.
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 colon and pancreatic cancer. PLoS One. 2014 Jun 3;9(6):e98556. doi: 10.1371/journal.pone.0098556. eCollection 2014.
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 cells. Pharmacol Res. 2013 Jun;72:61-8. doi: 10.1016/j.phrs.2013.03.010. Epub 2013 Apr 1.