NCT03908528

Alpha-Lipoic Acid in Breast Cancer Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Breast Cancer
• Chemotherapeutic Toxicity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)	600 mg Alpha-lipoic acid daily (an antioxidant that's in many foods, and it's made naturally in the investigator's bodies) with four cycles of doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by weekly taxol for 12 weeks..
OTHER	Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)	Placebo with four cycles of doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by weekly taxol for 12 weeks.

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2019-04-09
• Last updated: 2021-10-11

Locations

1 site across 1 country: Egypt