Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients

Launched by AIN SHAMS UNIVERSITY · May 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether taking Alpha Lipoic Acid can help reduce nerve-related side effects that some women experience during chemotherapy for breast cancer. Specifically, it involves 92 women aged 18 to 75 who are newly diagnosed with breast cancer and will be receiving Paclitaxel-based chemotherapy for 12 weeks. Participants will be randomly assigned to one of two groups: one will receive the chemotherapy alone, while the other will take a daily dose of 600 mg of Alpha Lipoic Acid along with their chemotherapy. The study will also involve blood tests and a series of cognitive tests to evaluate how well the brain is functioning before, during, and after treatment.

To be eligible for this trial, participants must be female breast cancer patients aged 18 to 75, diagnosed with Stage 1 to 3 non-metastatic breast cancer, and scheduled to begin Paclitaxel treatment. They should not have any prior neurological conditions, such as dementia or Parkinson's disease, and must be in good overall health. During the study, participants can expect regular check-ins and assessments to monitor their health and brain function. This trial is currently recruiting participants, and it's essential for those interested to discuss any questions or concerns with their healthcare provider.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female breast cancer patients aged 18 to 75 years old.
• • Patients with a first diagnosis of cancer and indication for first-line therapy with Paclitaxel-based chemotherapy.
• • Patients are those who are diagnosed with Stage 1 to 3 non-metastatic breast cancer.
• • Patients are intended to receive 12 weeks of paclitaxel (75 - 80 mg/m2) according to the TC protocol.
• • No previous neurological conditions (including dementia, Alzheimer's disease, Parkinson's disease) and taking no neurological-related drugs.
• • Normal hepatic and renal function (bilirubin ≤1.5 mg/dL, creatinine ≤2.0 mg/dL).
• • Eastern Cooperative Oncology Group (ECOG) performance status from 0 - 2.
• • Patient Health Questionnaire (PHQ) score from 0 - 9.
• Exclusion Criteria:
• • Hypersensitivity / Allergy to Alpha Lipoic Acid.
• • Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation).
• • New-onset neurological symptoms or presence of any neurological disorder.
• • Patients with known history or current treatment with neurological agents.
• • Alcohol abuse.
• • Current participation in any other clinical investigation.