Rosmalip® for Cancer Infections Prevention (OnCOVInf)
Primary Purpose
Infections, Covid19, Cancer
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Rosmalip®
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Infections
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
Sites / Locations
- Servicio de Oncología. Hospital Infanta Sofía.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rosmalip®
Placebo
Arm Description
Participants receive Rosmalip® (diterpene phenols 11,25 mg) 1 capsule orally once daily for 16 weeks
Participants receive Placebo 1 capsule matching Rosmalip® orally once daily for 16 weeks
Outcomes
Primary Outcome Measures
Number of infectious events
Number of infectious events according to International Sepsis Forum Consensus
Secondary Outcome Measures
Number of SARSCoV2 infections
Number of PCR confirmed SARSCoV2 infections
Changes in NLR (neutrophils to lymphocytes ratio).
Evolution of inflammatory markers
Changes in C-reactive protein
Evolution of inflammatory markers
Changes in ferritin
Evolution of inflammatory markers
Changes in transferrin
Evolution of inflammatory markers
Changes in number of peripheral blood mononuclear cells
Evolution of immune profile
Changes in number of CD4 and CD8 lymphocyte populations
Evolution of immune profile
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.
Full Information
NCT ID
NCT05080920
First Posted
October 16, 2020
Last Updated
September 18, 2023
Sponsor
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Collaborators
IMDEA Food, Universidad Autonoma de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05080920
Brief Title
Rosmalip® for Cancer Infections Prevention
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
Collaborators
IMDEA Food, Universidad Autonoma de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Covid19, Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosmalip®
Arm Type
Experimental
Arm Description
Participants receive Rosmalip® (diterpene phenols 11,25 mg) 1 capsule orally once daily for 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive Placebo 1 capsule matching Rosmalip® orally once daily for 16 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Rosmalip®
Intervention Description
Nutritional Supplement+Usual Care
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo+Usual Care
Primary Outcome Measure Information:
Title
Number of infectious events
Description
Number of infectious events according to International Sepsis Forum Consensus
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of SARSCoV2 infections
Description
Number of PCR confirmed SARSCoV2 infections
Time Frame
6 months
Title
Changes in NLR (neutrophils to lymphocytes ratio).
Description
Evolution of inflammatory markers
Time Frame
6 months
Title
Changes in C-reactive protein
Description
Evolution of inflammatory markers
Time Frame
6 months
Title
Changes in ferritin
Description
Evolution of inflammatory markers
Time Frame
6 months
Title
Changes in transferrin
Description
Evolution of inflammatory markers
Time Frame
6 months
Title
Changes in number of peripheral blood mononuclear cells
Description
Evolution of immune profile
Time Frame
6 months
Title
Changes in number of CD4 and CD8 lymphocyte populations
Description
Evolution of immune profile
Time Frame
6 months
Title
Evolution of Quality of life
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Casado Sáenz, MD
Organizational Affiliation
Servicio de Oncología. Hospital Infanta Sofía
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Ramírez de Molina, PhD
Organizational Affiliation
IMDEA Food
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guillermo Reglero Rada, PhD
Organizational Affiliation
CIAL_UAM_CSIC
Official's Role
Study Director
Facility Information:
Facility Name
Servicio de Oncología. Hospital Infanta Sofía.
City
San Sebastián de los Reyes
State/Province
Madrid
ZIP/Postal Code
28134
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
28555156
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.
Results Reference
background
PubMed Identifier
31450563
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.
Results Reference
result
PubMed Identifier
26452641
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.
Results Reference
result
PubMed Identifier
24615943
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.
Results Reference
result
PubMed Identifier
24892299
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.
Results Reference
result
PubMed Identifier
23557932
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.
Results Reference
result
Links:
URL
http://www.alibird.org/2020-CM/
Description
ALIBIRD_Therapeutic strategies for precision nutrition in cancer patients
Learn more about this trial
Rosmalip® for Cancer Infections Prevention
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