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

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

NCT ID: NCT06406127

Condition: Breast Cancer
Alpha Lipoic Acid
Paclitaxel
Neurologic Disorder
Chemotherapy

Conditions: Official terms:
Breast Neoplasms
Nervous System Diseases
Thioctic Acid

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Alpha Lipoic Acid 600 MG Oral Capsule
Description: Single 600 mg daily dose
Arm group label: Chemotherapy + Alpha Lipoic Acid

Other name: No drug

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 * Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study) - Tumor Necrotizing Factor- alpha (TNF-α) by ELISA.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

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Female breast cancer patients aged 18 to 75 years old. - Patients with a first diagnosis of cancer and indication for first-line therapy with Paclitaxel-based chemotherapy. - Patients are those who are diagnosed with Stage 1 to 3 non-metastatic breast cancer. - Patients are intended to receive 12 weeks of paclitaxel (75 - 80 mg/m2) according to the TC protocol. - No previous neurological conditions (including dementia, Alzheimer's disease, Parkinson's disease) and taking no neurological-related drugs. - Normal hepatic and renal function (bilirubin ≤1.5 mg/dL, creatinine ≤2.0 mg/dL). - Eastern Cooperative Oncology Group (ECOG) performance status from 0 - 2. - Patient Health Questionnaire (PHQ) score from 0 - 9. Exclusion Criteria: - Hypersensitivity / Allergy to Alpha Lipoic Acid. - Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation). - New-onset neurological symptoms or presence of any neurological disorder. - Patients with known history or current treatment with neurological agents. - Alcohol abuse. - Current participation in any other clinical investigation.

Gender: Female

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Dar El Salam Cancer Hospital (Harmel Hospital)

Address:
City: Cairo
Zip: 11559
Country: Egypt

Status: Recruiting

Contact:
Last name: Shaimaa M Shaker, Pharmacist

Phone: +2001119894331

Phone ext: +20
Email: shaimaamohamed63@gmail.com

Investigator:
Last name: Loay M Kassem, Physician
Email: Principal Investigator

Start date: April 1, 2024

Completion date: April 1, 2025

Lead sponsor:
Agency: Ain Shams University
Agency class: Other

Collaborator:
Agency: Dar EL Salam Cancer Hospital
Agency class: Other

Source: Ain Shams University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06406127
http://www.healthdirect.gov.au/mini-mental-state-examination-mmse