Alpha-Lipoic Acid in Breast Cancer Patients

NCT ID: NCT03908528

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-10-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chemotherapy plus Placebo for six Months

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Chemotherapy plus alpha lipoic acid for six Months

• 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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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..

Interventions

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..

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

Thiotacid 600 mg; placebo

Eligibility Criteria

Inclusion Criteria

1. All patients age ≥ 18 and < 70 years old with confirmed stage from stage I to stage III.

2. No evidence of metastases at initial assessment.

3. Patients has to have a good performance status (ECOG 0-2) according to Eastern Cooperative Oncology Group (ECOG) score.

4. Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin level ≥ 10g/dL).

5. 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).

6. Either pre operative or post operative chemotherapy are allowed.

Exclusion Criteria

1. Evidence of metastases at initial assessment.

2. Pregnancy or breast-feeding patients.

3. Prior exposure to neurotoxic chemotherapy was not allowed (no carboplatin, vincristine, vinblastine, paclitaxel, or docetaxol ) for 6 months prior study treatment.

4. Clinical evidence of serious cardiac illness (myocardial dysfunctional, angina pectoris requiring anti-angina medication, poorly controlled hypertension, and uncontrolled arrhythmias).

5. Patients with a reduced cardiac output with a left ventricular ejection fraction (LVEF) ejection fraction < 50%.

6. Patients who had evidence of pre-existing peripheral neuropathy resulting from another reason (diabetes).

7. Patients with a history of allergy to alpha-lipoic acid.

8. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reham A Elshafiey, PharmD

Role: PRINCIPAL_INVESTIGATOR

Damanhour University

Locations

Tanta Oncology Center

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 23614108 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35596774 (View on PubMed)

Other Identifiers

Alpha-Lipoic Acid

Identifier Type: -

Identifier Source: org_study_id