Post-Surgical ComplicationPhase 2NCT06087237
The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery
A Phase 2 study testing Pentoxifylline and paracetamol +ketorolac in people with Post-Surgical Complication and Breast Cancer Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-Surgical Complication, Breast Cancer Surgery
- What is being tested?
- Pentoxifylline and paracetamol +ketorolac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients aged 18 to 65 years
- Patients completed neoadjuvant chemotherapy cycles and scheduled for breast cancer surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Pentoxifylline in Reducing Post-surgical Complications in Patients Undergoing Breast Cancer Surgery
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.
Read the detailed description
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.
- Conditions
- Post-Surgical Complication, Breast Cancer Surgery
- Being tested
- Pentoxifylline, paracetamol +ketorolac
- Keywords
- pain, wound healing, post-surgery, breast cancer
- Medical subject headings
- Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called Trental tablets 400mg
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.
paracetamol +ketorolacDrug
Patients receive the usual treatment only:
paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pentoxifylline |
| Control group | Active comparator | Patients recieved the standard of care without pentoxifylline. Receives: Drug: paracetamol +ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours after surgery
Secondary outcomes (3)
Numbers of patients need rescue analgesia
The number of patients need rescue analgesia within 24 hours after surgery
Measured: 24 hours after surgery
Time for wound healing
The time for removal of surgical sutures
Measured: 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
Measured: Within 4 weeks of follow-up after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start30 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Surgical ComplicationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hamdy, Mansoura University
- Investigators
- Samar A. Dewidar, MSc, Study chair, clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura UniversityNoha O. Mansour, PhD, Study director, Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura UniversityMoetaza M. Soliman, PhD, Study director, Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura UniversityMohamed A. Shams, PhD, Study director, Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura UniversityOmar H. Abdelaleem, PhD, Principal investigator, Faculty pf medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087237
- Sponsor's protocol ID
- 2023-147
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40741002
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pentoxifylline in Reducing Post-surgical Complications in Patients Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06087237
- Acronym / sponsor ID
- 2023-147
- Conditions
- Post-Surgical Complication, Breast Cancer Surgery
- Keywords
- pain, wound healing, post-surgery, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline group | Experimental | Drug: PentoxifyllineTwo 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 | Drug: paracetamol +ketorolacPatients recieved the standard of care without pentoxifylline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult female patients aged 18 to 65 years
- Patients completed neoadjuvant chemotherapy cycles and scheduled for breast cancer surgery.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PentoxifyllineAlso: Trental tablets 400mgTwo 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. | Drug | Pentoxifylline group |
| paracetamol +ketorolacPatients receive the usual treatment only: paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours | Drug | Control group |
Primary outcome
Postoperative level of pain
Time frame: 24 hours after surgery
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).
3 secondary outcomes
Numbers of patients need rescue analgesia
Time frame: 24 hours after surgery
Time for wound healing
Time frame: Within 4 weeks of follow-up after the surgery
The incidence of post-surgical complications
Time frame: Within 4 weeks of follow-up after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 40741002Dewidar 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samar A. Dewidar, MSc study chair
clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Noha O. Mansour, PhD study director
Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
Moetaza M. Soliman, PhD study director
Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentoxifylline and paracetamol +ketorolac in people with Post-Surgical Complication and Breast Cancer Surgery, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative level of pain (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.