PhlebitisNCT06375850
Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.
A study testing Sesame oil and Saline solution in people with Phlebitis, run by Hospital Universitario Marqués de Valdecilla at 1 site in Spain.
Trial summary
Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses. For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phlebitis
- What is being tested?
- Sesame oil and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2022to 11 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be over 18 years of age.
- To be conscious and have a cognitive state that allows him/her to give consent to participate in the study.
- Be diagnosed with a neoplasm that requires chemotherapy treatment.
- To be a carrier of a CVP in the upper extremity as vascular access for chemotherapy administration.
Who cannot join
- Being allergic to sesame oil.
- Be allergic to nuts.
- Not being able to speak, read and write in Spanish.
- Last days or palliative situation.
Trial locations and contacts
1 site in 1 country.
Virginia Meneses Campos contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Virginia Meneses Campos, +34942202520, virginia.meneses@scsalud.es
Virginia Meneses Campos
About this study
Official title: Effects of Topical Sesame Oil in the Prevention of Chemotherapy-associated Peripheral Venous Catheter Phlebitis: Clinical Trial.
Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.
For 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.
Read more
Phlebitis 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.
Phlebitis 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.
The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.
With 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.
- Conditions
- Phlebitis
- Being tested
- Sesame oil, Saline solution
- Keywords
- Neoplasms, Antineoplastic Agents, Phlebitis, Sesame Oil, Catheterization, Peripheral
- Medical subject headings
- Phlebitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sesame oilOther
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.
Once the venous access has been channeled, it will be fixed with, leaving the puncture point visible for future monitoring.
The sesame oil chosen for the project is "Sesame bio - 100% pure vegetable oil from the Naissance brand.
To 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.
Saline solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will be administered 2 drops of sesame oil daily along the channeled vein, about 3 centimeters from the insertion point. Receives: Other: Sesame oil |
| Control | Placebo comparator | This arm will be administered 2 drops of physiological saline daily along the channeled vein, about 3 centimeters from the insertion point. Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically
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.
Measured: one year
Secondary outcomes (1)
Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start5 Jun 2022
- Primary completion11 Feb 2025 (estimated)
- Study completion11 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PhlebitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Meneses Campos, Hospital Universitario Marqués de Valdecilla
- Investigators
- Virginia Meneses Campos, Principal investigator, EmployeeVirginia Meneses, Study director, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375850
- Sponsor's protocol ID
- Effects of topical sesame oil
- Status last verified
- Apr 2024
- First submitted
- 29 Feb 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27508916Wu 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.
PubMed 29946873Saini 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.
PubMed 30783328Behnamfar 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.
PubMed 31453801Bagheri-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.
PubMed 26120338Bigdeli 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.
PubMed 31003690Goulart 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.
PubMed 32324314Nekuzad 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.
PubMed 24250538Liu 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.
PubMed 34343193
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Sesame Oil in the Prevention of Chemotherapy-associated Peripheral Venous Catheter Phlebitis: Clinical Trial.
- ClinicalTrials.gov ID
- NCT06375850
- Acronym / sponsor ID
- Effects of topical sesame oil
- Conditions
- Phlebitis
- Keywords
- Neoplasms, Antineoplastic Agents, Phlebitis, Sesame Oil, Catheterization, Peripheral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Universitario Marqués de ValdecillaUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 11 Feb 2025 (estimated)
- Study completion
- 11 May 2025 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.
For 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.
Phlebitis 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.
Phlebitis 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.
The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.
With 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Sesame oilThis arm will be administered 2 drops of sesame oil daily along the channeled vein, about 3 centimeters from the insertion point. |
| Control | Placebo comparator | Other: Saline solutionThis arm will be administered 2 drops of physiological saline daily along the channeled vein, about 3 centimeters from the insertion point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be over 18 years of age.
- To be conscious and have a cognitive state that allows him/her to give consent to participate in the study.
- Be diagnosed with a neoplasm that requires chemotherapy treatment.
- To be a carrier of a CVP in the upper extremity as vascular access for chemotherapy administration.
Key exclusion criteria (4 listed)
- Being allergic to sesame oil.
- Be allergic to nuts.
- Not being able to speak, read and write in Spanish.
- Last days or palliative situation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sesame oilA 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. Once the venous access has been channeled, it will be fixed with, leaving the puncture point visible for future monitoring. The sesame oil chosen for the project is "Sesame bio - 100% pure vegetable oil from the Naissance brand. To 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. | Other | Intervention |
| Saline solutionAfter 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. | Other | Control |
Primary outcome
Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically
Time frame: one year
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.
1 secondary outcome
Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 27508916Urbanetto 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.
- Background: PubMed 29946873Wu 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.
- Background: PubMed 30783328Saini 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.
- Background: PubMed 31453801Behnamfar 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.
- Background: PubMed 26120338Bagheri-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.
- Background: PubMed 31003690Bigdeli 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.
- Background: PubMed 32324314Goulart 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.
- Background: PubMed 24250538Nekuzad 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.
- Background: PubMed 34343193Liu 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.
- National Cancer InstituteLink provided by the sponsor.
- Spanish Society of Medical OncologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Meneses Campos contact
Virginia Meneses Campos principal investigator
Employee
Virginia Meneses study director
Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sesame oil and Saline solution in people with Phlebitis, run by Hospital Universitario Marqués de Valdecilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginia Meneses Campos (+34685953641, virginia.meneses@scsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06375850, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.