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Trial Title:
The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery
NCT ID:
NCT06087237
Condition:
Post-Surgical Complication
Breast Cancer Surgery
Conditions: Official terms:
Breast Neoplasms
Pentoxifylline
Conditions: Keywords:
pain
wound healing
post-surgery
breast cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Pentoxifylline
Description:
400 mg pentoxifylline oral tablets three times per day starting from the day before
surgery till two weeks after the surgery.
Arm group label:
Pentoxifylline group
Other name:
Trental tablets 400mg
Intervention type:
Drug
Intervention name:
Placebo
Description:
placebo tablets three times per day starting from the day before surgery till two weeks
after the surgery.
Arm group label:
Control group
Other name:
starch tablets
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adult female patients aged 18 to 65 years
2. Patients completed neoadjuvant chemotherapy cycles and scheduled for breast cancer
surgery.
Exclusion Criteria:
1. Patients on treatment regimen of phosphodiesterase inhibitors
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology center of Mansoura University
Address:
City:
Mansoura
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Omar Hamdy Abdelaleem, PhD
Start date:
October 30, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Mansoura University
Agency class:
Other
Source:
Mansoura University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06087237