Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
Ain Shams University
92 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
Summary
92 female cancer patients, aged from 18 to 75 years old (with a first diagnosis of breast cancer) who will receive Paclitaxel-based chemotherapy (12 weeks) as first line therapy, will be enrolled in the study and will be randomly assigned to either: * Group I: will receive the chemotherapy protocol or * Group II: will receive the chemotherapy protocol plus 600 mg daily dose of Alpha Lipoic Acid for 14 weeks (one week before the start of paclitaxel and continue till one week after the end of paclitaxel). \* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study) * Tumor Necrotizing Factor- alpha (TNF-α) by ELISA. * Brain-Derived Neurotrophic Factor (BDNF) by ELISA. \* All patients will be subjected to 6 tests/questionnaires (week 1 - week 12 - week 24) to predict the functionality of the brain: * Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) version 3 * Mini-Cog Test * Mini Mental State Examination (MMSE) * Controlled Oral Word Association Test (COWAT) * Hopkins Verbal Learning Test (HVLT) * Trail Making Test (TMT)
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Single 600 mg daily dose
Locations(1)
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NCT06406127