NCT05080920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

October 28, 2020

Completed
12 months until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

October 16, 2020

Last Update Submit

September 18, 2023

Conditions

InfectionsCovid19Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of infectious events

    Number of infectious events according to International Sepsis Forum Consensus

    6 months

Secondary Outcomes (8)

  • Number of SARSCoV2 infections

    6 months

  • Changes in NLR (neutrophils to lymphocytes ratio).

    6 months

  • Changes in C-reactive protein

    6 months

  • Changes in ferritin

    6 months

  • Changes in transferrin

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Rosmalip®

EXPERIMENTAL

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

Dietary Supplement: Rosmalip®

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Rosmalip®DIETARY_SUPPLEMENT

Nutritional Supplement+Usual Care

Rosmalip®
PlaceboOTHER

Placebo+Usual Care

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a solid cancer under active Anticancer Treatment (including Chemotherapy, Immunotherapy, Hormone Therapy, Targeted Therapy)
  • Informed consent signature

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Oncología. Hospital Infanta Sofía.

San Sebastián de los Reyes, Madrid, 28134, Spain

Location

Related Publications (8)

  • 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.

    PMID: 28555156BACKGROUND

  • 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.

    PMID: 31450563RESULT

  • 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.

    PMID: 26452641RESULT

  • 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.

    PMID: 24615943RESULT

  • 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.

    PMID: 24892299RESULT

  • 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.

    PMID: 23557932RESULT

  • Gomez de Cedron M, Moreno-Rubio J, de la O Pascual V, Alvarez B, Villarino M, Sereno M, Gomez-Raposo C, Roa S, Lopez Gomez M, Merino-Salvador M, Jimenez-Gordo A, Falagan S, Aguayo C, Zambrana F, Tabares B, Garrido B, Cruz-Gil S, Fernandez Diaz CM, Fernandez LP, Molina S, Crespo MC, Ouahid Y, Montoya JJ, Ramos Ruiz R, Reglero G, Ramirez de Molina A, Casado E. Randomized clinical trial in cancer patients shows immune metabolic effects exerted by formulated bioactive phenolic diterpenes with potential clinical benefits. Front Immunol. 2025 Feb 17;16:1519978. doi: 10.3389/fimmu.2025.1519978. eCollection 2025.

    PMID: 40034703DERIVED

  • Bouzas A, Gomez de Cedron M, Colmenarejo G, Laparra-Llopis JM, Moreno-Rubio J, Montoya JJ, Reglero G, Casado E, Tabares B, Sereno M, Ramirez de Molina A. Phenolic diterpenes from Rosemary supercritical extract inhibit non-small cell lung cancer lipid metabolism and synergise with therapeutic drugs in the clinic. Front Oncol. 2022 Nov 9;12:1046369. doi: 10.3389/fonc.2022.1046369. eCollection 2022.

    PMID: 36439419DERIVED

Related Links

MeSH Terms

Conditions

InfectionsCOVID-19Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Enrique Casado Sáenz, MD

    Servicio de Oncología. Hospital Infanta Sofía

    PRINCIPAL INVESTIGATOR

  • Ana Ramírez de Molina, PhD

    IMDEA Food

    STUDY DIRECTOR

  • Guillermo Reglero Rada, PhD

    CIAL_UAM_CSIC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Oncology

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 18, 2021

Study Start

October 28, 2020

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

ES(1)