Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05080920
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2020-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rosmalip® for Cancer Infections Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants receive Rosmalip® capsule or Placebo tablet matching Rosmalip® orally once daily for 16 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of infectious events', 'timeFrame': '6 months', 'description': 'Number of infectious events according to International Sepsis Forum Consensus'}], 'secondaryOutcomes': [{'measure': 'Number of SARSCoV2 infections', 'timeFrame': '6 months', 'description': 'Number of PCR confirmed SARSCoV2 infections'}, {'measure': 'Changes in NLR (neutrophils to lymphocytes ratio).', 'timeFrame': '6 months', 'description': 'Evolution of inflammatory markers'}, {'measure': 'Changes in C-reactive protein', 'timeFrame': '6 months', 'description': 'Evolution of inflammatory markers'}, {'measure': 'Changes in ferritin', 'timeFrame': '6 months', 'description': 'Evolution of inflammatory markers'}, {'measure': 'Changes in transferrin', 'timeFrame': '6 months', 'description': 'Evolution of inflammatory markers'}, {'measure': 'Changes in number of peripheral blood mononuclear cells', 'timeFrame': '6 months', 'description': 'Evolution of immune profile'}, {'measure': 'Changes in number of CD4 and CD8 lymphocyte populations', 'timeFrame': '6 months', 'description': 'Evolution of immune profile'}, {'measure': 'Evolution of Quality of life', 'timeFrame': '6 months', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infections', 'Covid19', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '28555156', 'type': 'BACKGROUND', '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.'}, {'pmid': '31450563', 'type': 'RESULT', '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.'}, {'pmid': '26452641', 'type': 'RESULT', '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.'}, {'pmid': '24615943', 'type': 'RESULT', '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.'}, {'pmid': '24892299', 'type': 'RESULT', '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.'}, {'pmid': '23557932', 'type': 'RESULT', '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.'}, {'pmid': '40034703', 'type': 'DERIVED', 'citation': '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': '36439419', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.alibird.org/2020-CM/', 'label': 'ALIBIRD\\_Therapeutic strategies for precision nutrition in cancer patients'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a solid cancer under active Anticancer Treatment (including Chemotherapy, Immunotherapy, Hormone Therapy, Targeted Therapy)\n* Informed consent signature\n\nExclusion Criteria:\n\n* Allergies to fish\n* Vitamin, Antioxidants consumers and who would no accept to stop taking them 1 week before and during the study\n* Disphagia\n* Bilirrubin higher than 1.5 Upper Normal Limit (UNL)/ Creatinin \\> 1.5 UNL\n* Severe organic dysfunction\n* Cardiac dysfunction\n* Cholangitis/ Biliary tract obstruction\n* Immunodeficiency or Immflamatory disease (HIV, Inflammatory Bowel Disease, Collagenosis)\n* Dementia or Psychiatric severe disease\n* Pregnancy or Breastfeeding\n* Previous diseases that interfere lipid carrier absorption'}, 'identificationModule': {'nctId': 'NCT05080920', 'acronym': 'OnCOVInf', 'briefTitle': 'Rosmalip® for Cancer Infections Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'Rosmalip®-OnCOVInf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosmalip®', 'description': 'Participants receive Rosmalip® (diterpene phenols 11,25 mg) 1 capsule orally once daily for 16 weeks', 'interventionNames': ['Dietary Supplement: Rosmalip®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive Placebo 1 capsule matching Rosmalip® orally once daily for 16 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Rosmalip®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutritional Supplement+Usual Care', 'armGroupLabels': ['Rosmalip®']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo+Usual Care', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28134', 'city': 'San Sebastián de los Reyes', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Servicio de Oncología. Hospital Infanta Sofía.', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}], 'overallOfficials': [{'name': 'Enrique Casado Sáenz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Servicio de Oncología. Hospital Infanta Sofía'}, {'name': 'Ana Ramírez de Molina, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IMDEA Food'}, {'name': 'Guillermo Reglero Rada, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CIAL_UAM_CSIC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares', 'class': 'OTHER'}, 'collaborators': [{'name': 'IMDEA Food', 'class': 'OTHER'}, {'name': 'Universidad Autonoma de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Oncology', 'investigatorFullName': 'Enrique Casado Sáenz', 'investigatorAffiliation': 'Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares'}}}}