Impact of Alpha Lipoic Acid on Neurological Effects of Chemotherapy in Breast Cancer Patients
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
This study is testing if adding Alpha Lipoic Acid to chemotherapy helps women with breast cancer feel better and reduces nerve-related side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo, El Malek El Saleh) |
| Trial ID | NCT06406127 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 92 female patients aged 18 to 75 who have been newly diagnosed with non-metastatic breast cancer and are set to receive Paclitaxel-based chemotherapy. Participants will be randomly assigned to either receive the chemotherapy alone or the chemotherapy along with a daily dose of 600 mg of Alpha Lipoic Acid for 14 weeks. The study aims to assess neurological changes through various cognitive tests and blood biomarkers at three different time points: before treatment, after treatment, and six months post-treatment. The goal is to evaluate whether Alpha Lipoic Acid can mitigate neurological side effects associated with chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are female breast cancer patients aged 18 to 75 who are receiving their first line of Paclitaxel-based chemotherapy.
Not a fit: Patients with pre-existing neurological conditions or those who are allergic to Alpha Lipoic Acid may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce neurological side effects in breast cancer patients undergoing chemotherapy, improving their quality of life.
How similar studies have performed: While the use of Alpha Lipoic Acid in this context is relatively novel, previous studies have suggested potential benefits in reducing oxidative stress and neurological symptoms in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo, El Malek El Saleh
- Dar El Salam Cancer Hospital (Harmel Hospital) — Cairo, El Malek El Saleh, Egypt (Recruiting)
Study contacts
- Principal investigator: Manal H El Hamamsy, Doctorate — Ain Shams University - Faculty of Pharmacy
- Study coordinator: Shaimaa M Shaker, Pharmacist
- Email: shaimaamohamed63@gmail.com
- Phone: +2001119894331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.