Alpha-Lipoic Acid in Breast Cancer Patients

NCT03908528 | Completed DMC

• 1 other identifier: Alpha-Lipoic Acid
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Chemotherapeutic Toxicity

Keywords

alpha-lipoic acid; taxol; Adriamycin; cyclophosphamide; breast cancer; Brain Natriuretic Peptide (BNP).; Neurotensin; TNF-alpha

Outcome Measures

Primary Outcomes (4)

• Cardiotoxcity assessment

  serum Brain Natriuretic Peptide (BNP) level

  six months

• Neurotoxicity assessment

  Neurotensin level

  six months

• oxidative stress and inflammatory markers

  TNF-alpha level

  six months

• MDA

  Malondialdehyde

  six months

Study Arms (2)

Chemotherapy plus Placebo for six Months

EXPERIMENTAL

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

Other: Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)

Chemotherapy plus alpha lipoic acid for six Months

EXPERIMENTAL

• Group two: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks in addition to oral 600 mg alpha lipoic acid (ALA) once daily.

Dietary Supplement: Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)

Interventions

Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol) DIETARY_SUPPLEMENT

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..

Also known as: Thiotacid 600 mg

Chemotherapy plus alpha lipoic acid for six Months

Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol) OTHER

Placebo with four cycles of doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by weekly taxol for 12 weeks.

Also known as: placebo

Chemotherapy plus Placebo for six Months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients age ≥ 18 and \< 70 years old with confirmed stage from stage I to stage III.
• No evidence of metastases at initial assessment.
• Patients has to have a good performance status (ECOG 0-2) according to Eastern Cooperative Oncology Group (ECOG) score.
• Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin level ≥ 10g/dL).
• Patients with adequate liver function (serum creatinine \< 1.5 mg/dL) and adequate renal function (serum creatinine \< 1.5 mg/dL, creatinine clearance (CrCl) \> 45 ml/min).
• Either pre operative or post operative chemotherapy are allowed.

You may not qualify if:

• Evidence of metastases at initial assessment.
• Pregnancy or breast-feeding patients.
• Prior exposure to neurotoxic chemotherapy was not allowed (no carboplatin, vincristine, vinblastine, paclitaxel, or docetaxol ) for 6 months prior study treatment.
• Clinical evidence of serious cardiac illness (myocardial dysfunctional, angina pectoris requiring anti-angina medication, poorly controlled hypertension, and uncontrolled arrhythmias).
• Patients with a reduced cardiac output with a left ventricular ejection fraction (LVEF) ejection fraction \< 50%.
• Patients who had evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes).
• Patients with a history of allergy to alpha-lipoic acid.
• Concomitant use of multivitamins (vitamin E), opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication modifying agents (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are not allowed

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Tanta Oncology Center

Tanta, Gharbia Governorate, Egypt

Location

Related Publications (2)

• Kapoor S. The Anti-neoplastic Effects of Alpha-Lipoic Acid: Clinical Benefits in System Tumors besides Lung Carcinomas. Korean J Thorac Cardiovasc Surg. 2013 Apr;46(2):162-3. doi: 10.5090/kjtcs.2013.46.2.162. Epub 2013 Apr 9. No abstract available.

  PMID: 23614108 BACKGROUND

• Werida RH, Elshafiey RA, Ghoneim A, Elzawawy S, Mostafa TM. Role of alpha-lipoic acid in counteracting paclitaxel- and doxorubicin-induced toxicities: a randomized controlled trial in breast cancer patients. Support Care Cancer. 2022 Sep;30(9):7281-7292. doi: 10.1007/s00520-022-07124-0. Epub 2022 May 21.

  PMID: 35596774 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Thioctic Acid; Drug Therapy; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Therapeutics; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Reham A Elshafiey, PharmD

  Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 9, 2019
• Study Start: March 1, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)