The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery
NCT ID: NCT06087237
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2023-10-30
2024-06-30
Brief Summary
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Detailed Description
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It aims to evaluate the efficacy of adjuvant pentoxifylline in reducing postoperative pain and improving wound healing in breast cancer patients undergoing mastectomy surgery.
Participants will take standard of care treatment with oral pentoxifylline 400 mg 2 hours before surgery, then oral pentoxifylline 400 mg three times per day for 4 weeks, while the control group will only take standard of care. The researchers will compare the difference in pain score and time for wound healing relative to the control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pentoxifylline group
Two 400 mg extended-release pentoxifylline oral tablets are administered 2 hours before surgery, then one tablet three times per day after surgery, and continue for four weeks after the surgery. Standard of care for pain management, including paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours.
Pentoxifylline
Two 400 mg extended-release pentoxifylline oral tablets are administered 2 hours before surgery, then one tablet three times per day after surgery, and continued for four weeks after the surgery.
Standard of care for pain management, including paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours.
Control group
Patients recieved the standard of care without pentoxifylline.
paracetamol +ketorolac
Patients receive the usual treatment only:
paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours
Interventions
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Pentoxifylline
Two 400 mg extended-release pentoxifylline oral tablets are administered 2 hours before surgery, then one tablet three times per day after surgery, and continued for four weeks after the surgery.
Standard of care for pain management, including paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours.
paracetamol +ketorolac
Patients receive the usual treatment only:
paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients completed neoadjuvant chemotherapy cycles and scheduled for breast cancer surgery.
Exclusion Criteria
2. Patients who are taking antiplatelet or anticoagulant treatment
3. Patients who are allergic to phosphodiesterase inhibitors
4. History of recent hemorrhagic events
5. Active peptic ulcer
6. History of psychological problems
7. History of chronic pain management
8. Pregnancy or breastfeeding
18 Years
65 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Omar Hamdy
Doctor
Principal Investigators
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Samar A. Dewidar, MSc
Role: STUDY_CHAIR
clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Noha O. Mansour, PhD
Role: STUDY_DIRECTOR
Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Moetaza M. Soliman, PhD
Role: STUDY_DIRECTOR
Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Mohamed A. Shams, PhD
Role: STUDY_DIRECTOR
Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Omar H. Abdelaleem, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty pf medicine, Mansoura University
Locations
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Oncology center of Mansoura University
Al Mansurah, , Egypt
Countries
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References
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Dewidar SA, Mansour NO, Hamdy O, Elebedy DA, Soliman MM, Shams MEE. Efficacy of using pentoxifylline in patients undergoing breast cancer surgery. Front Pharmacol. 2025 Jul 16;16:1560805. doi: 10.3389/fphar.2025.1560805. eCollection 2025.
Other Identifiers
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2023-147
Identifier Type: -
Identifier Source: org_study_id
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