Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes

Status Recruiting

Clinical Trial 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 * Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study) - Tumor Necrotizing Factor- alpha (TNF-α) by ELISA.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)

Clinical Trial Description

92 Female Cancer patients will be randomized to 2 groups, the first group will receive the alpha lipoic acid beside their chemotherapy regimen and the other group will only receive the chemotherapy regimen. Both groups will be watched for any changes in their neurological behaviors by asking and receiving answers on the questionnaires that were mentioned before. This will be done in 3 different time margins: - Before starting the chemotherapeutic regimen - after ending the chemotherapeutic regimen - after 6 months of receiving the chemotherapeutic regimen this will show even the late symptoms and effects of the chemotherapy. Also serum biomarkers will be measured (TNF alpha and BDNF) 2 times; one before starting the chemotherapeutic regimen and the other after ending the treatment. Throughout the treatment process, both groups will be monitored for any side effects concerning the alpha lipoic acid or the chemotherapeutic regimen. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06406127
Study type	Interventional
Source	Ain Shams University
Contact	Shaimaa M Shaker, Pharmacist
Phone	+2001119894331
Email	shaimaamohamed63@gmail.com
Status	Recruiting
Phase	Phase 4
Start date	April 1, 2024
Completion date	April 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms