Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients

NCT ID: NCT06135493

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-12
• Study Completion Date: 2025-03-30

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

Study Design

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

Study Groups

Control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention arm

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

Group Type: EXPERIMENTAL

Losartan

Intervention Type: DRUG

Using losartan to prevent paclitaxel-induced peripheral neuropathy

Interventions

Losartan

Using losartan to prevent paclitaxel-induced peripheral neuropathy

Intervention Type: DRUG

Eligibility Criteria

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

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

Sponsors

Future University in Egypt

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mahmoud Ahmed Shawqy Mahmoud

Principle Invistigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Countries

Egypt

Other Identifiers

REC-FPFUE-30/2023

Identifier Type: -

Identifier Source: org_study_id