Alpha-Lipoic Acid in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title: Role of Alpha-Lipoic Acid Against Chemotherapy Induced Toxicities in Breast Cancer Patients

Status Completed

Clinical Trial Summary

• Investigate the ability of alpha lipoic acid to counter act anthracycline associated cardiotoxicity and cumulative taxens-related PN in patients with breast cancer.

Clinical Trial Description

Fifty breast cancer patients with stage from stage I to stage III will be involved in this study. Staging is done according to the American joint committee on cancer: TNM staging of breast cancer.

• All participants will be recruited from Tanta Oncology Center. The study will be approved by Research Ethics Committee of Damanhour University. All participants will give their consent.

• All 64 patients will be scheduled to receive 4 cycles of AC: cycled every 21 days followed by weekly cycle of taxol for 12 weeks.

Patients will be classified as follow:

• Group one: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus placebo.

• Group two: 32 patients will receive the same regimen as group 1 in addition to oral 600 mg alpha lipoic acid (ALA) once daily.

All patients will be submitted to:

1. Full patient history and clinical examination.

2. Venous blood will be collected before the first cycle of chemotherapy and after the last cycle of chemotherapy.

1- Cardio-toxcity assessment: i. Echo-cardiogram. ii. Troponin I. iii. The Brain Natriuretic Peptide (BNP). 2- Neurotoxicity assessment: i. National Cancer Institute common Terminology criteria for Adverse Effect grading: NCI-CTCAE version 4.0.

ii. Neurotoxicity questionnaire from the validated Functional Assessment of cancer therapy/gynecologic oncology group taxane specific neurotoxicity questionnaire: FACT-Taxane.

iii. Neurotensin 3- Oxidative stress and inflammatory markers: i. Malondialdehyde (MDA). ii. TNF-alpha ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapeutic Toxicity

• NCT number: NCT03908528
• Study type: Interventional
• Source: Damanhour University
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Completion date: October 30, 2020