CompletedNot Applicable

Alpha-Lipoic Acid in Breast Cancer Patients

Egypt64 participantsStarted 2019-03-01

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Cardiotoxcity assessment

Timeframe: six months

Neurotoxicity assessment

Timeframe: six months

oxidative stress and inflammatory markers

Timeframe: six months

MDA

Timeframe: six months

Trial details

NCT IDNCT03908528

SponsorDamanhour University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-30

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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