Alpha-Lipoic Acid in Breast Cancer Patients
Condition: Breast Cancer; Chemotherapeutic Toxicity
MeSH terms: Breast Neoplasms
Study type: Interventional

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
    

Intervention name(s): Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol); Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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..; Placebo with four cycles of doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by weekly taxol for 12 weeks.
Other intervention name(s): Thiotacid 600 mg; placebo
Intervention MeSH terms: Thioctic Acid; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind study, 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 four cycles of AC followed by weekly taxol for 12 weeks plus oral 600 mg alpha lipoic acid (ALA) once daily.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: alpha-lipoic acid; taxol; Adriamycin; cyclophosphamide; breast cancer; Brain Natriuretic Peptide (BNP).; Neurotensin; TNF-alpha