Actively Recruiting
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
Led by Ain Shams University · Updated on 2024-05-09
92
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Ain Shams University
Lead Sponsor
D
Dar EL Salam Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 \* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study) * Tumor Necrotizing Factor- alpha (TNF-α) by ELISA.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)
CONDITIONS
Official Title
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female breast cancer patients aged 18 to 75 years old.
- First diagnosis of breast cancer with indication for first-line Paclitaxel-based chemotherapy.
- Diagnosed with Stage 1 to 3 non-metastatic breast cancer.
- Planned to receive 12 weeks of Paclitaxel chemotherapy (75 - 80 mg/m2) following the TC protocol.
- No previous neurological conditions such as dementia, Alzheimer's disease, or Parkinson's disease and not taking neurological drugs.
- Normal liver and kidney function (bilirubin 61.5 mg/dL, creatinine 62.0 mg/dL).
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2.
- Patient Health Questionnaire (PHQ) score between 0 and 9.
You will not qualify if you...
- Allergy or hypersensitivity to Alpha Lipoic Acid.
- Any condition that prevents chemotherapy, such as pregnancy or breastfeeding.
- New neurological symptoms or existing neurological disorders.
- History of or current treatment with neurological medications.
- Alcohol abuse.
- Participation in any other clinical trial currently.
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Trial Site Locations
Total: 1 location
1
Dar El Salam Cancer Hospital (Harmel Hospital)
Cairo, El Malek El Saleh, Egypt, 11559
Actively Recruiting
Research Team
S
Shaimaa M Shaker, Pharmacist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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