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

Ain Shams University

Status and phase: Enrolling; Phase 4

Conditions: Breast Cancer; Chemotherapy; Paclitaxel; Alpha Lipoic Acid; Neurologic Disorder

Treatments: Drug: Alpha Lipoic Acid 600 MG Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06406127

RHDIRB2020110301 REC #247

Details and patient eligibility

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  * Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study)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)

Full 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.

Enrollment: 92 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Chemotherapy + Alpha Lipoic Acid

Experimental group

Description:

will receive chemotherapy (paclitaxel for 12 weeks) + Alpha Lipoic Acid for 14 weeks (one week before the start of paclitaxel and continue for one week after the end of paclitaxel).

Treatment:

Drug: Alpha Lipoic Acid 600 MG Oral Capsule

Chemotherapy only

No Intervention group

Description:

will receive chemotherapy only (paclitaxel for 12 weeks).