Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-29 @ 9:25 AM
Study NCT ID:
NCT06375850
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010689', 'term': 'Phlebitis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012715', 'term': 'Sesame Oil'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-05-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically', 'timeFrame': 'one year', 'description': 'Sesame oil will be applied in the intervention groups, with the aim of assessing whether its application decreases the occurrence of phlebitis in oncology patients with irritating and high osmolarity intravenous medication.'}], 'secondaryOutcomes': [{'measure': 'Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters', 'timeFrame': 'one year', 'description': 'Registration of other adverse effects related to chemotherapy administration through a peripheral catheter: extravasation, number of cannulations during admission, catheter duration and reason for withdrawal.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoplasms', 'Antineoplastic Agents', 'Phlebitis', 'Sesame Oil', 'Catheterization', 'Peripheral'], 'conditions': ['Phlebitis']}, 'referencesModule': {'references': [{'pmid': '27508916', 'type': 'BACKGROUND', 'citation': 'Urbanetto Jde S, Peixoto CG, May TA. Incidence of phlebitis associated with the use of peripheral IV catheter and following catheter removal. Rev Lat Am Enfermagem. 2016 Aug 8;24:e2746. doi: 10.1590/1518-8345.0604.2746.'}, {'pmid': '29946873', 'type': 'BACKGROUND', 'citation': 'Wu XF, Yu YJ, Ying LM, Tan WF, Zhan XY, Wang LC. Hot Compress with Chinese Herbal Salt Packets Reducing PICC Catheter Complications: A Randomized Controlled Trial. Chin J Integr Med. 2018 Nov;24(11):809-814. doi: 10.1007/s11655-018-2913-y. Epub 2018 Jun 27.'}, {'pmid': '30783328', 'type': 'BACKGROUND', 'citation': 'Saini V, Samra T, Ahuja N, Sethi S. A prospective randomized study to evaluate safety and efficacy of heparin topical solution (1000 IU/ml) compared to heparin topical gel (200 IU/g) in prevention of infusion-associated phlebitis. Indian J Pharmacol. 2018 Nov-Dec;50(6):344-349. doi: 10.4103/ijp.IJP_201_17.'}, {'pmid': '31453801', 'type': 'BACKGROUND', 'citation': 'Behnamfar N, Parsa Yekta Z, Mojab F, Kazem Naeini SM. The effect of nigella sativa oil on the prevention of phlebitis induced by chemotherapy: a clinical trial. Biomedicine (Taipei). 2019 Sep;9(3):20. doi: 10.1051/bmdcn/2019090320. Epub 2019 Aug 27.'}, {'pmid': '26120338', 'type': 'BACKGROUND', 'citation': 'Bagheri-Nesami M, Shorofi SA, Hashemi-Karoie SZ, Khalilian A. The effects of sesame oil on the prevention of amiodarone-induced phlebitis. Iran J Nurs Midwifery Res. 2015 May-Jun;20(3):365-70.'}, {'pmid': '31003690', 'type': 'BACKGROUND', 'citation': 'Bigdeli Shamloo MB, Nasiri M, Maneiy M, Dorchin M, Mojab F, Bahrami H, Naseri MS, Kiarsi M. Effects of topical sesame (Sesamum indicum) oil on the pain severity of chemotherapy-induced phlebitis in patients with colorectal cancer: A randomized controlled trial. Complement Ther Clin Pract. 2019 May;35:78-85. doi: 10.1016/j.ctcp.2019.01.016. Epub 2019 Feb 2.'}, {'pmid': '32324314', 'type': 'BACKGROUND', 'citation': 'Goulart CB, Custodio CS, Vasques CI, Ferreira EB, Diniz Dos Reis PE. Effectiveness of topical interventions to prevent or treat intravenous therapy-related phlebitis: A systematic review. J Clin Nurs. 2020 Jul;29(13-14):2138-2149. doi: 10.1111/jocn.15266. Epub 2020 May 20.'}, {'pmid': '24250538', 'type': 'BACKGROUND', 'citation': 'Nekuzad N, Ashke Torab T, Mojab F, Alavi-Majd H, Azadeh P, Ehtejab G. Effect of external use of sesame oil in the prevention of chemotherapy-induced phlebitis. Iran J Pharm Res. 2012 Fall;11(4):1065-71.'}, {'pmid': '34343193', 'type': 'BACKGROUND', 'citation': 'Liu B, Wu Z, Lin C, Li L, Kuang X. Applicability of TIVAP versus PICC in non-hematological malignancies patients: A meta-analysis and systematic review. PLoS One. 2021 Aug 3;16(8):e0255473. doi: 10.1371/journal.pone.0255473. eCollection 2021.'}], 'seeAlsoLinks': [{'url': 'https://www.cancer.gov/', 'label': 'National Cancer Institute'}, {'url': 'https://seom.org/', 'label': 'Spanish Society of Medical Oncology'}]}, 'descriptionModule': {'briefSummary': 'Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.\n\nFor the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis.\n\nPhlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward.\n\nPhlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism.\n\nThe existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.\n\nWith the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over 18 years of age.\n* To be conscious and have a cognitive state that allows him/her to give consent to participate in the study.\n* Be diagnosed with a neoplasm that requires chemotherapy treatment.\n* To be a carrier of a CVP in the upper extremity as vascular access for chemotherapy administration.\n\nExclusion Criteria:\n\n* Being allergic to sesame oil.\n* Be allergic to nuts.\n* Not being able to speak, read and write in Spanish.\n* Last days or palliative situation.'}, 'identificationModule': {'nctId': 'NCT06375850', 'briefTitle': 'Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Marqués de Valdecilla'}, 'officialTitle': 'Effects of Topical Sesame Oil in the Prevention of Chemotherapy-associated Peripheral Venous Catheter Phlebitis: Clinical Trial.', 'orgStudyIdInfo': {'id': 'Effects of topical sesame oil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This arm will be administered 2 drops of sesame oil daily along the channeled vein, about 3 centimeters from the insertion point.', 'interventionNames': ['Other: Sesame oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'This arm will be administered 2 drops of physiological saline daily along the channeled vein, about 3 centimeters from the insertion point.', 'interventionNames': ['Other: Saline solution']}], 'interventions': [{'name': 'Sesame oil', 'type': 'OTHER', 'description': 'A peripheral venous catheter will be channeled to the patient admitted to the unit and who requires it. The indications included in the guide for channeling venous access of the Marqués de Valdecilla hospital will be followed.\n\nOnce the venous access has been channeled, it will be fixed with, leaving the puncture point visible for future monitoring.\n\nThe sesame oil chosen for the project is "Sesame bio - 100% pure vegetable oil from the Naissance brand.\n\nTo perform the procedure, two drops of sesame oil will be applied daily by the nurse in charge of the patient during the morning shift in the area about 2 cm above the insertion point and coinciding with the course of the vein channeled for intravenous therapy. A small massage of the area of application will be performed, with an approximate extension of 3x3cm, until its absorption. It will be left to dry in the air.', 'armGroupLabels': ['Intervention']}, {'name': 'Saline solution', 'type': 'OTHER', 'description': 'After cannulation of the vein following the same procedure as explained in the intervention arm, patients belonging to the control arm will be administered two drops of saline solution.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Virginia Meneses Campos', 'role': 'CONTACT', 'email': 'virginia.meneses@scsalud.es', 'phone': '+34942202520'}, {'name': 'Virginia Meneses Campos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'centralContacts': [{'name': 'Virginia Meneses Campos', 'role': 'CONTACT', 'email': 'virginia.meneses@scsalud.es', 'phone': '+34685953641'}, {'name': 'Virginia Meneses Campos', 'role': 'CONTACT', 'phone': '+34942202520'}], 'overallOfficials': [{'name': 'Virginia Meneses Campos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Employee'}, {'name': 'Virginia Meneses', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Employee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Marqués de Valdecilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Virginia Meneses Campos', 'investigatorAffiliation': 'Hospital Universitario Marqués de Valdecilla'}}}}