"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"

NCT ID: NCT05189535

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-03
• Study Completion Date: 2023-09-28

Brief Summary

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.

Detailed Description

Paclitaxel induced peripheral neuropathy (PIPN) starts early during therapy and may worsen even after cessation and affect mainly sensory neurons. The symptoms of neuropathy include pain, tingling, cold-sensitivity and numbness that typically presents in a stocking glove distribution. The pathogenesis of PIPN may be attributed to drug accumulation in dorsal root ganglia causing increase in inflammatory cytokines, immune mediators and dysregulation of calcium subunits which in turn increases pain. It also causes oxidative stress in sensory axons leading to axon demyelination, increased sensitization to signal transduction, release of pro-inflammatory mediators and activation of apoptosis.

Many animal studies and clinical trials have shown pentoxifylline to have a significant anti-inflammatory and antioxidant effect. It also preserved nerve conduction velocity and ameliorated mechanical hyperalgesia. Pentoxifylline showed a prominent reduction in neuropathic pain in diabetic patients. These effects were mainly due to the ability of pentoxifylline to reduce TNF-α and MDA levels. So, pentoxifylline is a drug of interest due to its ability to ameliorate neuro-inflammation and oxidative stress which play a critical role in PIPN pathogenesis.

Conditions

Breast Cancer Female; Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

pentoxifylline 400 mg

Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and pentoxifylline 400 mg twice daily for the paclitaxel treatment period.

Group Type: EXPERIMENTAL

Pentoxifylline

Intervention Type: DRUG

Pentoxifylline 400 mg oral tablet twice daily for 12 weeks.

Paclitaxel

Intervention Type: DRUG

Paclitaxel I.V 80 mg/m2 weekly

Placebo

Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and placebo twice daily for the paclitaxel treatment period..

Group Type: PLACEBO_COMPARATOR

Paclitaxel

Intervention Type: DRUG

Paclitaxel I.V 80 mg/m2 weekly

Placebo

Intervention Type: DRUG

placebo

Interventions

Pentoxifylline

Pentoxifylline 400 mg oral tablet twice daily for 12 weeks.

Intervention Type: DRUG

Paclitaxel

Paclitaxel I.V 80 mg/m2 weekly

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Trental; Taxol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sondos Sherif Ismail

Clinical Pharmacy, Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University hospitals

Cairo, Abbasia, Egypt

Countries

Egypt

Other Identifiers

s2192648

Identifier Type: -

Identifier Source: org_study_id