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OncoMatch/Clinical Trials/NCT06406127

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

Is NCT06406127 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Alpha Lipoic Acid 600 MG Oral Capsule for breast cancer.

Phase 4RecruitingAin Shams UniversityNCT06406127Data as of May 2026

Treatment: Alpha Lipoic Acid 600 MG Oral Capsule92 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 \* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study) * Tumor Necrotizing Factor- alpha (TNF-α) by ELISA.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)

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Required: Stage I, II, III

Stage 1 to 3 non-metastatic breast cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Kidney function

creatinine ≤2.0 mg/dl

Liver function

bilirubin ≤1.5 mg/dl

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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