Clinical trial · Interventional
Effect of Alpha Lipoic Acid on Chemotherapy Induced Neurological Changes in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 \* Blood samples will be withdrawn 2 times (week 1 and week 12) to measure the following: (Stored in -80 C till the end of the study) * Tumor Necrotizing Factor- alpha (TNF-α) by ELISA.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)
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alpha Lipoic Acid | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
| Neurologic Disorder | — | UNRESOLVED | — |
| Paclitaxel | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha Lipoic Acid 600 MG Oral Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy + Alpha Lipoic Acid
- 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).
- interventionNames
- Drug: Alpha Lipoic Acid 600 MG Oral Capsule
- type
- NO_INTERVENTION
- label
- Chemotherapy only
- description
- will receive chemotherapy only (paclitaxel for 12 weeks).
Primary outcomes (1)
- measure
- Tumor Necrotizing Factor Alpha Serum Levels
- timeFrame
- At baseline of treatment and After 12 weeks of the paclitaxel-based therapy (at the end of therapy)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (20)
- RESULTNCD Countdown 2030 collaborators. NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4. Lancet. 2018 Sep 22;392(10152):1072-1088. doi: 10.1016/S0140-6736(18)31992-5. Epub 2018 Sep 20. PMID 30264707
- RESULTRostom Y, Abdelmoneim SE, Shaker M, Mahmoud N. Presentation and management of female breast cancer in Egypt. East Mediterr Health J. 2022 Oct 30;28(10):725-732. doi: 10.26719/emhj.22.076. PMID 36382727
- RESULTBrown T, McElroy T, Simmons P, Walters H, Ntagwabira F, Wang J, Byrum SD, Allen AR. Cognitive impairment resulting from treatment with docetaxel, doxorubicin, and cyclophosphamide. Brain Res. 2021 Jun 1;1760:147397. doi: 10.1016/j.brainres.2021.147397. Epub 2021 Mar 8. PMID 33705788
- RESULTBellens A, Roelant E, Sabbe B, Peeters M, van Dam PA. A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial. Breast. 2020 Oct;53:23-32. doi: 10.1016/j.breast.2020.06.003. Epub 2020 Jun 12. PMID 32554133
- RESULTJanelsins MC, Kohli S, Mohile SG, Usuki K, Ahles TA, Morrow GR. An update on cancer- and chemotherapy-related cognitive dysfunction: current status. Semin Oncol. 2011 Jun;38(3):431-8. doi: 10.1053/j.seminoncol.2011.03.014. PMID 21600374
- RESULTLee JH, Nan A. Combination drug delivery approaches in metastatic breast cancer. J Drug Deliv. 2012;2012:915375. doi: 10.1155/2012/915375. Epub 2012 Apr 26. PMID 22619725
- RESULTEmadi A, Jones RJ, Brodsky RA. Cyclophosphamide and cancer: golden anniversary. Nat Rev Clin Oncol. 2009 Nov;6(11):638-47. doi: 10.1038/nrclinonc.2009.146. Epub 2009 Sep 29. PMID 19786984