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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 Ayadi AL-Mostakbal Oncology Center. The study will be approved by Research Ethics Committee of Damanhour University. All participants will give their consent.

- All 50 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: 25 patients will receive four cycles of AC followed by weekly taxol for 12 weeks.

- Group two: 25 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. MMP 3 a marker for neuropathic pain. iv. Neurotensin 3- Oxidative stress and inflammatory markers: i. Malondialdehyde (MDA). ii. TNF-alpha ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03908528
Study type Interventional
Source Damanhour University
Contact Rehab H Werida, Lecturer
Phone 01005359968
Status Recruiting
Phase N/A
Start date March 1, 2019
Completion date October 1, 2019

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