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OpenTrials
Completed

NCT Number: NCT06135493

Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients

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.

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Key information

Conditions

Peripheral Neuropathy Due to Chemotherapy Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan

Drug

Using losartan to prevent paclitaxel-induced peripheral neuropathy

Primary outcomes

  1. Development of paclitaxel-induced peripheral neuropathy

    Time frame: 12 weeks

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

Secondary outcomes

  1. Patient QOL

    Time frame: 12 weeks

    Patient quality of life will be assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)

  2. Pain Severity

    Time frame: 12 Weeks

    Pain intensity will be assessed through Visaul Analogue Scale Scale 0-10

  3. Serum biomarker

    Time frame: 12 weeks

    Level of Nerve growth factor (NGF) in Serum

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Efficacy of Losartan in the Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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