Clinical trial NCT06186700: Effect of Pentoxifylline on Preventing Chemotherapy-induced Toxicities in Patients with Breast Cancer
Official title: Effect of Pentoxifylline on Preventing Chemotherapy-induced Toxicities in Patients with Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer Female
Breast Cancer Patients
Neoadjuvant Therapy
Doxorubicin
Taxane-induced Peripheral Neuropathy
Keywords: neoadjuvant chemotherapy, pentoxiphyllin, doxorubicin, cyclophosphamide, mucositis, quality of life
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial is a randomized clinical trial that aims to assess the usefulness of adding pentoxifylline to the neoadjuvant chemotherapy treatment protocol of doxorubicin/cyclophosphamide fllowed by taxane for breast cancer patients to decrease the incidence of developing toxicities, 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 chemotherapy cycles. The researchers will compare the incidence and grade of mucosities, neuropathy, and other chemotherapy-related toxicities in the presence or absence of oral pentoxifylline.


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.

Primary outcomes:
measure: The incidence of neuropathy in the two groups using Common Terminology Criteria Adverse Event grading
timeFrame: 6 months
Secondary outcomes:
measure: The incidence of oral mucositis in the two groups using Common Terminology Criteria Adverse Event grading
timeFrame: 6 months
measure: The incidence of anemia in the two groups using Common Terminology Criteria Adverse Event grading
timeFrame: 6 months
measure: The incidence of Febrile neutropenia in the two groups using Common Terminology Criteria Adverse Event grading
timeFrame: 6 months
measure: the incidence of gastrointestinal side effects including: abdominal discomfort, bloating, diarrhea, constipation will be assessed in the two groups using Common Terminology Criteria Adverse Event grading
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Oncology Center of Mansoura University
Study officials:
References: