Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-04-13 @ 10:47 PM
Study NCT ID:
NCT06406127
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
Sponsor:
Ain Shams University
Organization:
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\* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)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 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)
* 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\* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)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)
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:
True
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?: