Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients

Peripheral Neuropathy Due to Chemotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135493
• Other study ID #: REC-FPFUE-30/2023
• Status: Recruiting
• Phase: Phase 2
• Start date: December 12, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Future University in Egypt
• Contact: Alaa Mahmoud Ahmed Shawqy, Bachelor's
• Phone: 01155935619
• Email: Aalaa.Mahmoud[@]fue.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy Due to Chemotherapy

Intervention

Drug:
• Losartan
Using losartan to prevent paclitaxel-induced peripheral neuropathy

Locations

Country	Name	City	State
Egypt	Breast Cancer Comprehensive Center of the National Cancer Institute, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of paclitaxel-induced peripheral neuropathy	Incidence of Development of paclitaxel-induced peripheral neuropathy	12 weeks
Primary	Grade of neuropathy	Neuropathy grade according to NCI Common Terminology Criteria for Adverse Events	12 weeks
Secondary	Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)	Patient quality of life will be assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)	12 weeks
Secondary	Biomarker	Level of Nerve growth factor (NGF) in Serum	12 weeks