Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients

Phase 2

Completed

• Conditions: Peripheral Neuropathy Due to Chemotherapy
• Interventions: Drug: Losartan

• Registration Number: NCT06135493
• Lead Sponsor: Future University in Egypt

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-11
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Study Start: 2023-12-12
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Losartan	These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting plus losartan 100mg

Primary Outcome Measures

Name	Time	Method
Development of paclitaxel-induced peripheral neuropathy	12 weeks	Incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)

Secondary Outcome Measures

Name	Time	Method
Patient QOL	12 weeks	Patient quality of life will be assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)
Pain Severity	12 Weeks	Pain intensity will be assessed through Visaul Analogue Scale Scale 0-10
Serum biomarker	12 weeks	Level of Nerve growth factor (NGF) in Serum

Trial Locations

Locations (1)

Breast Cancer Comprehensive Center of the National Cancer Institute, Cairo University; 🇪🇬 Cairo, Egypt