The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing post surgical complications for breast cancer patients undergoing breast cancer surgery. It aims to evaluate the efficacy of pentoxifylline on postoperative pain and wound healing. Participants will take oral pentoxifylline then post surgical oral pentoxifylline three times per day for 2 weeks. The researchers will compare the difference in pain score and wound healing relative to the control group.

Detailed Description
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The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing post surgical 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 oral oral pentoxifylline 400 mg three times per day 400 mg three times for the day before surgery then oral pentoxifylline 400 mg three times per day for 2 weeks while the control group will take placebo tablet one day before surgey and placebo tablets three times per day for 2 weeks after surgery. the researchers will compare the difference in pain score and time for wound healing relatively to the control group.

Official Title
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The Efficacy of Pentoxifylline in Reducing Post-surgical Complications in Patients Undergoing Breast Cancer Surgery

Conditions
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Post-Surgical Complication, Breast Cancer Surgery

Intervention / Treatment
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* Drug: Pentoxifylline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female patients aged 18 to 65 years Patients completed neoadjuvant chemotherapy cycles and scheduled for breast cancer surgery. Exclusion Criteria: Patients on treatment regimen of phosphodiesterase inhibitors Patients who are taking antiplatelet or anticoagulant treatment Patients who are allergic to phosphodiesterase inhibitors History of recent hemorrhagic events Active peptic ulcer History of psychological problems History of chronic pain management Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentoxifylline group<br>oral Pentoxifylline 400 mg three times per day starting the day before the surgery till 2 weeks after surgery | Drug: Pentoxifylline<br>* 400 mg pentoxifylline oral tablets three times per day starting from the day before surgery till two weeks after the surgery.<br>* Other names: Trental tablets 400mg;|
| Placebo Comparator: Control group<br>oral placebo tablets three times per day starting the day before the surgery till 2 weeks after surgery | Drug: Placebo<br>* placebo tablets three times per day starting from the day before surgery till two weeks after the surgery.<br>* Other names: starch tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Visual Analogue Score (VAS) ranging from 0 (indicating no pain) to 10 (expressing the pain as bad as it could possibly be). | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 (hours) to first request analgesia | The first time after surgery at which the patient needs analgesia. | within 24 hours after surgery | 
| Time for wound healing | The time for removal of surgical sutures | Within 2-3 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 2-3 weeks of follow-up after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, pain, wound healing, post-surgery