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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

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