Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients

Future University in Egypt

Status and phase: Completed; Phase 2

Conditions: Peripheral Neuropathy Due to Chemotherapy

Treatments: Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT06135493

REC-FPFUE-30/2023

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Control arm

No Intervention group

Description:

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

Intervention arm

Experimental group

Description:

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

Treatment:

Drug: Losartan