RecruitingPhase 4NCT06406127

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


Sponsor

Ain Shams University

Enrollment

92 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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 \* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study) * Tumor Necrotizing Factor- alpha (TNF-α) by ELISA.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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether alpha lipoic acid — a natural antioxidant supplement — can protect the nerves of women with breast cancer who are receiving paclitaxel-based chemotherapy, which commonly causes nerve damage (tingling, numbness, or pain in the hands and feet). **You may be eligible if...** - You are a woman between 18 and 75 years old - You have been newly diagnosed with non-metastatic breast cancer (Stage 1 to 3) - You are scheduled to receive 12 weeks of paclitaxel chemotherapy (TC protocol) - You have normal liver and kidney function - Your general health score is 0–2 (ECOG) - You have no prior neurological conditions and are not taking neurological medications - Your depression screening is mild or less (PHQ score 0–9) **You may NOT be eligible if...** - You are allergic to alpha lipoic acid - You are pregnant or breastfeeding - You have any neurological condition or are taking medications that affect the nervous system - You have a history of alcohol abuse - You are currently in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlpha Lipoic Acid 600 MG Oral Capsule

Single 600 mg daily dose


Locations(1)

Dar El Salam Cancer Hospital (Harmel Hospital)

Cairo, El Malek El Saleh, Egypt

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NCT06406127


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