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Trial Title:
Effect of Pentoxifylline on Preventing Chemotherapy-induced Mucositis in Patients With Breast Cancer
NCT ID:
NCT06186700
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Mucositis
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Pentoxifylline
Conditions: Keywords:
neoadjuvant chemotherapy, pentoxiphyllin, doxorubicin, cyclophosphamide, mucositis, quality of life
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Pentoxifylline
Description:
Pentoxiphylline tablets three times per day for the treatment period of neoadjuvant
chemotherapy cycles of doxorubicin/ cyclophosphamide
Arm group label:
Pentoxifylline group
Other name:
Intravenous doxorubicin
Other name:
Intravenous cyclophosphamide
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo tablets three times per day for the treatment period of neoadjuvant chemotherapy
cycles of doxorubicin/ cyclophosphamide
Arm group label:
Control group
Other name:
Intravenous doxorubicin
Other name:
Intravenous cyclophosphamide
Summary:
This clinical trial is a randomized controlled trial that aims to assess the usefulness
of adding pentoxifylline to the neoadjuvant chemotherapy treatment protocol of
doxorubicin/cyclophosphamide for breast cancer patients to decrease the incidence of
developing oral mucositis, downgrade the mucositis symptoms, alleviate the associated
pain using the visual analogue scale, and enhance the quality of patient life using the
EQ-5D-3L questionnaire. The participant will administer Pentoxifylline oral tablets three
times per day along with the treatment protocol, starting from the first
doxorubicin/cyclophosphamide cycle till the end of the fourth cycle. The researchers will
compare the mucositis incidence and grade in the presence or absence of oral
pentoxifylline.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Adult female patients >18 years old with histologic confirmation of invasive breast
cancer
2. Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/
cyclophosphamide followed by paclitaxel (AC/T)
3. Adequate hepatic, renal, and bone marrow functions
Exclusion Criteria:
1. Patients on a 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. patients who have mouth or teeth problem.
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
Start date:
December 25, 2023
Completion date:
April 5, 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/NCT06186700
