Alpha-Lipoic Acid in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Chemotherapeutic Toxicity; Breast Cancer
• Interventions: Other: Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol); Dietary Supplement: Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)

• Registration Number: NCT03908528
• Lead Sponsor: Damanhour University

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

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-09
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy plus Placebo for six Months	Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)	• Group one: 32 patients will receive four cycles of AC followed by weekly taxol for 12 weeks plus Placebo.
Chemotherapy plus alpha lipoic acid for six Months	Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)	• 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.

Primary Outcome Measures

Name	Time	Method
MDA	six months	Malondialdehyde
Neurotoxicity assessment	six months	Neurotensin level
Cardiotoxcity assessment	six months	serum Brain Natriuretic Peptide (BNP) level
oxidative stress and inflammatory markers	six months	TNF-alpha level

Trial Locations

Locations (1)

Tanta Oncology Center; 🇪🇬 Tanta, Gharbia, Egypt