- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06176339
Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
March 12, 2024 updated by: Omar Hamdy, Mansoura University
"Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"
Breast cancer, a leading cause of cancer-related mortality in women worldwide, has spurred the investigation of novel therapeutic approaches.
Pentoxifylline (PTX), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs.
This study aims to assess PTX's impact when added to neoadjuvant chemotherapy protocols in breast cancer patients, with the goal of improving treatment outcomes and reducing associated toxicities.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samar A. Dewidar, PhD student
- Phone Number: +201558333468
- Email: s.dewidar@mans.edu.eg
Study Contact Backup
- Name: Noha O. Mansour, PhD
- Email: dr.nohamansour@gmail.com
Study Locations
-
-
-
Mansoura, Egypt
- Oncology Center of Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult female patients >18 years old with histologic confirmation of invasive breast cancer
- Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T)
- Adequate hepatic, renal, and bone marrow functions
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pentoxyphyllin group
Patients will undergo a treatment plan determined by the multidisciplinary team.
This involves four cycles of intravenous (IV) doxorubicin at a dose of 60 mg/m2 along with IV cyclophosphamide at 600 mg/m2 per cycle.
Following this, taxane will be administered.
Additionally, patients are prescribed 400 mg pentoxifylline tablets to be taken three times daily.
|
Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.
Other Names:
|
Placebo Comparator: Control group
Patients will undergo a treatment plan determined by the multidisciplinary team.
This involves four cycles of intravenous (IV) doxorubicin at a dose of 60 mg/m2 along with IV cyclophosphamide at 600 mg/m2 per cycle.
Following this, taxane will be administered.
Additionally, patients will take placebo tablets three times daily.
|
Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative reduction in tumor size after neoadjuvant chemotherapy treatment
Time Frame: 6 months
|
Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of patients achieving a pathological complete response
Time Frame: 6 months
|
The number of patients achieving a pathological complete response after the completion of neoadjuvant chemotherapy cycles
|
6 months
|
The relative change of left ventricular ejection fraction (LVEF)
Time Frame: 3 months
|
The alterations in left ventricular ejection fraction (LVEF) assessed through echocardiography after four cycles of doxorubicin/cyclophosphamide compared to its baseline level
|
3 months
|
The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5
Time Frame: 2 months
|
Assessing the grade of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5
|
2 months
|
The relative change of liver function tests
Time Frame: 6 months
|
The change in liver function tests Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), bilirubin level after neoadjuvant chemotherapy compared to their levels at baseline.
|
6 months
|
The change in Serum Creatinine concentration
Time Frame: 6 months
|
The change in Serum Creatinine concentration after neoadjuvant chemotherapy compared to baseline level.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Omar Hamdy Abdelaleem, PhD, Oncology Center, Faculty of medicine, Mansoura University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2023
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
December 1, 2023
First Submitted That Met QC Criteria
December 10, 2023
First Posted (Actual)
December 19, 2023
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Platelet Aggregation Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Antioxidants
- Phosphodiesterase Inhibitors
- Free Radical Scavengers
- Radiation-Protective Agents
- Cyclophosphamide
- Doxorubicin
- Liposomal doxorubicin
- Taxane
- Pentoxifylline
Other Study ID Numbers
- 2023-147-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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