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The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing postsurgical complications for breast cancer patients undergoing breast cancer surgery. It aims to evaluate the efficacy of pentoxifylline on postoperative pain and wound healing.
The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing postsurgical complications for breast cancer patients undergoing mastectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentoxifylline group | Experimental | 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. |
|
| Control group | Active Comparator | Patients recieved the standard of care without pentoxifylline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative level of pain | Postoperative level of pain immediately after the surgery and every 6 hours until 24 hours after surgery using the Numeric Rating Score (NRS) ranging from 0 (indicating no pain) to 10 (expressing the pain as bad as it could possibly be). | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of patients need rescue analgesia | The number of patients need rescue analgesia within 24 hours after surgery | 24 hours after surgery |
| Time for wound healing | The time for removal of surgical sutures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samar A. Dewidar, MSc | clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University | Study Chair |
| Noha O. Mansour, PhD | Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University | Study Director |
| Moetaza M. Soliman, PhD | Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University | Study Director |
| Mohamed A. Shams, PhD | Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University | Study Director |
| Omar H. Abdelaleem, PhD | Faculty pf medicine, Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology center of Mansoura University | Al Mansurah | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40741002 | Derived | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
|
| paracetamol +ketorolac | Drug | Patients receive the usual treatment only: paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours |
|
| Within 4 weeks of follow-up after the surgery |
| The incidence of post-surgical complications | The incidence of seroma, hematoma, surgical site infection, and skin flap necrosis | Within 4 weeks of follow-up after the surgery |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |