Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients

NCT06135493 | Completed Phase 2

• 1 other identifier: REC-FPFUE-30/2023
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect. The purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Keywords

Paclitaxel; Breast Cancer; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Development of paclitaxel-induced peripheral neuropathy

  Incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)

  12 weeks

Secondary Outcomes (3)

• Patient QOL

  12 weeks

• Pain Severity

  12 Weeks

• Serum biomarker

  12 weeks

Study Arms (2)

Control arm

NO INTERVENTION

These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting

Intervention arm

EXPERIMENTAL

These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting plus losartan 100mg

Drug: Losartan

Interventions

Losartan DRUG

Using losartan to prevent paclitaxel-induced peripheral neuropathy

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive paclitaxel 80 mg/m2.

You may not qualify if:

• Known hypersensitivity to Losartan.
• Not Known Hypertensive patients
• Not Known Diabetic patients
• Treatment with Losartan/ARBs/ACE-I prior to the study.
• Previous neuropathy
• Renal impairment (Serum creatinine \> 2 mg/dl)
• Significant liver disease: liver enzymes 2 folds the upper normal limit
• Metastatic breast cancer
• Pregnancy or lactation
• Taking other medication for neuropathic pain
• Significant Hypotension

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Breast Cancer Comprehensive Center of the National Cancer Institute, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Interventions

Losartan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Invistigator

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: December 12, 2023
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)