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 range

18 Years – 70 Years

Sex

FEMALE

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 70 Years

Sex

FEMALE

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).