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

NCT05189535 | Completed Phase 2

• 1 other identifier: s2192648
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; Peripheral Neuropathy

Keywords

Breast cancer; pentoxifylline; paclitaxel; Taxol; peripheral neuropathy; Trental

Outcome Measures

Primary Outcomes (1)

• Incidence of Paclitaxel induced-peripheral neuropathy

  Number of patients reported neuropathy due to paclitaxel

  12 weeks

Secondary Outcomes (3)

• Grade of severity of Paclitaxel induced-peripheral neuropathy in patients who developed neuropathy

  at baseline and on weekly bases for 12 weeks

• Evaluation of Safety and tolerability of pentoxifylline

  evaluation on weekly bases for 12 weeks.

• The need for dose reduction or drug discontinuation in pentoxifylline and placebo arm.

  12 weeks

Other Outcomes (4)

• Serum tumor necrosis factor alpha (TNF-α)

  at baseline and after 12 weeks

• Serum malondialdehyde (MDA)

  at baseline and after 12 weeks

• The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale

  at baseline, week 1 in each cycle (cycle length is 21 days) up to 12 weeks and at week 12.

Study Arms (2)

pentoxifylline 400 mg

EXPERIMENTAL

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

Drug: Pentoxifylline; Drug: Paclitaxel

Placebo

PLACEBO COMPARATOR

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

Drug: Paclitaxel; Drug: Placebo

Interventions

Pentoxifylline DRUG

Pentoxifylline 400 mg oral tablet twice daily for 12 weeks.

Also known as: Trental

pentoxifylline 400 mg

Paclitaxel DRUG

Paclitaxel I.V 80 mg/m2 weekly

Also known as: Taxol

Placebo; pentoxifylline 400 mg

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Abbasia, 11566, Egypt

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Breast Neoplasms

Interventions

Pentoxifylline; Paclitaxel

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy, Ain Shams University

Model Details: A prospective, randomized, placebo controlled

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: January 12, 2022
• Study Start: October 3, 2021
• Primary Completion: September 18, 2023
• Study Completion: September 28, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)