Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406127
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-19
Brief Title:
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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Blood samples will be withdrawn 2 times week 1 and week 12 to measure the following Stored in -80 C till the end of the study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 testsquestionnaires 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
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Blood samples will be withdrawn 2 times week 1 and week 12 to measure the following Stored in -80 C till the end of the study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 testsquestionnaires 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None