Back to resultsThe Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery
Primary Purpose
Post-Surgical Complication, Breast Cancer Surgery
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pentoxifylline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-Surgical Complication focused on measuring pain, wound healing, post-surgery, breast cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pentoxifylline group
Control group
Arm Description
oral Pentoxifylline 400 mg three times per day starting the day before the surgery till 2 weeks after surgery
oral placebo tablets three times per day starting the day before the surgery till 2 weeks after surgery
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Numbers of patients need rescue analgesia
The number of patients need rescue analgesia within 24 hours after surgery
Time (hours) to first request analgesia
The first time after surgery at which the patient needs analgesia.
Time for wound healing
The time for removal of surgical sutures
The incidence of post-surgical complications
The incidence of seroma, hematoma, surgical site infection, and skin flap necrosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06087237
Brief Title
The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery
Official Title
The Efficacy of Pentoxifylline in Reducing Post-surgical Complications in Patients Undergoing Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Surgical Complication, Breast Cancer Surgery
Keywords
pain, wound healing, post-surgery, breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pentoxifylline group
Arm Type
Experimental
Arm Description
oral Pentoxifylline 400 mg three times per day starting the day before the surgery till 2 weeks after surgery
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
oral placebo tablets three times per day starting the day before the surgery till 2 weeks after surgery
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental tablets 400mg
Intervention Description
400 mg pentoxifylline oral tablets three times per day starting from the day before surgery till two weeks after the surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
starch tablets
Intervention Description
placebo tablets three times per day starting from the day before surgery till two weeks after the surgery.
Primary Outcome Measure Information:
Title
Postoperative level of pain
Description
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).
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Numbers of patients need rescue analgesia
Description
The number of patients need rescue analgesia within 24 hours after surgery
Time Frame
24 hours after surgery
Title
Time (hours) to first request analgesia
Description
The first time after surgery at which the patient needs analgesia.
Time Frame
within 24 hours after surgery
Title
Time for wound healing
Description
The time for removal of surgical sutures
Time Frame
Within 2-3 weeks of follow-up after the surgery
Title
The incidence of post-surgical complications
Description
The incidence of seroma, hematoma, surgical site infection, and skin flap necrosis
Time Frame
Within 2-3 weeks of follow-up after the surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar A. Dewidar, PhD student
Phone
+201558333468
Email
s.dewidar@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Noha O. Mansour, PhD
Phone
+201221610667
Email
dr.nohamansour@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samar A. Dewidar, PhD student
Organizational Affiliation
clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Noha O. Mansour, PhD
Organizational Affiliation
Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Moetaza M. Soliman, associate professor
Organizational Affiliation
Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed A. Shams, professor
Organizational Affiliation
Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Omar H. Abdelaleem, PhD
Organizational Affiliation
Faculty pf medicine, Mansoura University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery
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