Clinical trial · Interventional
"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"
"Evaluation of the Effect of Pentoxifylline on the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"
NCT05189535CI-TRIAL-00073196completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pentoxifylline | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pentoxifylline 400 mg
- description
- Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and pentoxifylline 400 mg twice daily for the paclitaxel treatment period.
- interventionNames
- Drug: Pentoxifylline
- Drug: Paclitaxel
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and placebo twice daily for the paclitaxel treatment period..
- interventionNames
- Drug: Paclitaxel
- Drug: Placebo
Primary outcomes (1)
- measure
- Incidence of Paclitaxel induced-peripheral neuropathy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (18-80 years old). * Female patients. * Pathologically proved breast cancer. * Breast cancer patients who will receive adjuvant and neoadjuvant weekly paclitaxel for 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance ≤ 2 * Adequate bone marrow function. * Adequate liver and kidney function. Exclusion Criteria: * Patients with preexisting clinical neuropathy. * Patients with diabetes mellitus. * Metastatic breast cancer. * Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics. * Patients treated with medications that increase the risk of neuropathy. * Hypersensitivity to pentoxifylline or xanthine derivatives. * Patients with recent (within 1 month) surgery, myocardial infarction (MI), intracranial or retinal bleeding or active peptic ulcer. * Patients at high risk for bleeding or taking medications that increase risk of bleeding.
References
Publications (0)
Data not yet available
No reference posted for this study.