Clinical trial · Interventional
Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy
Dose Finding and Tolerability Study of Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Peripheral Neuropathy
- 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)
This study is being done because peripheral neuropathy, a condition that interrupts sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel. The purpose of this study is to assess the safety and tolerability of ALA and to find the best dose of ALA in patients that receive chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha lipoic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alpha lipoic acid
- description
- Oral administration three times daily (morning, mid-day, night)
- interventionNames
- Drug: Alpha lipoic acid
Primary outcomes (1)
- measure
- Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile
- timeFrame
- 4 months
- description
- Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.
Secondary outcomes (3)
- measure
- Proportion of Patients Who Complete the Proposed Regimen of Daily ALA
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Diagnosis of Breast cancer. 2. Breast cancer must meet the following criteria: * Early stage breast cancer (stages I, IIA) must be estrogen receptor (ER) positive AND low tumor grade (histopathologic grade 1 or 2) * Locally advanced breast cancer (LABC) (stages IIB, IIIA, IIB as defined by the Union for International Cancer Control and American Joint Committee on Cancer) must be ER positive, HER2 positive or HER2 negative, AND satisfy the following requirements: high endocrine responsiveness (defined as greater than 50% of tumor cells staining for hormone receptors), Grade 1 or 2 histological grade, less than 4 nodes positive, absence of extensive peritumoral vascular invasion, AND pathological tumor size less than 5 cm. * Inflammatory breast cancer (IBC) (stage IIIC) * Metastatic breast cancer (stage IV) 3. Must be receiving single agent paclitaxel in their prescribed chemotherapy regimen. 4. Age \> 18 years. There is no upper age limit for participation in this study. 5. Required lab values: AST, ALT, creatinine 6. Women of childbearing potential and sexually active males must agree to use contraception while on study. 7. ECOG performance status 0,1,2 8. All patients must have given signed, informed consent. Exclusion Criteria 1. Breast cancer meeting the following criteria: * Breast cancer stage 0 * Early stage breast cancer (stages I, IIA) that is ER negative OR higher tumor grade (histopathologic grade greater than 2) * Stages I, II, and IIIA triple negative breast cancer (negative for estrogen receptors, progesterone receptors, and HER2) * LABC (stages IIB, IIIA, IIB) if they have low endocrine responsiveness (defined as less than 50% of tumor cells staining for hormone receptors), Grade 3 histological grade, 4 or more nodes positive, presence of extensive peritumoral vascular invasion, OR pathological tumor size greater than 5 cm * LABC (stages IIB, IIIA, IIB) that are ER negative 2. Evidence of pre-existing peripheral neuropathy as determined by baseline Michigan neuropathy screening instrument score \> 2. 3. Previous chemotherapy treatment of any kind. 4. AST and ALT \>2 times upper limit of normal; Creatinine \> 2.0 mg/dL. 5. Current use of medications or substances known to be associated with peripheral neuropathy. 6. Use of ALA or other anti-oxidant supplements during the prior three months. 7. Diabetes mellitus or use of medications known to lower blood sugar. 8. Participation in any other experimental trial.
References
Publications (13)
- BACKGROUNDSiau C, Xiao W, Bennett GJ. Paclitaxel- and vincristine-evoked painful peripheral neuropathies: loss of epidermal innervation and activation of Langerhans cells. Exp Neurol. 2006 Oct;201(2):507-14. doi: 10.1016/j.expneurol.2006.05.007. Epub 2006 Jun 22. PMID 16797537
- BACKGROUNDMcCarty MF, Barroso-Aranda J, Contreras F. The "rejuvenatory" impact of lipoic acid on mitochondrial function in aging rats may reflect induction and activation of PPAR-gamma coactivator-1alpha. Med Hypotheses. 2009 Jan;72(1):29-33. doi: 10.1016/j.mehy.2008.07.043. Epub 2008 Sep 11. PMID 18789599
- BACKGROUNDMelli G, Taiana M, Camozzi F, Triolo D, Podini P, Quattrini A, Taroni F, Lauria G. Alpha-lipoic acid prevents mitochondrial damage and neurotoxicity in experimental chemotherapy neuropathy. Exp Neurol. 2008 Dec;214(2):276-84. doi: 10.1016/j.expneurol.2008.08.013. Epub 2008 Sep 9. PMID 18809400
- BACKGROUNDZiegler D, Ametov A, Barinov A, Dyck PJ, Gurieva I, Low PA, Munzel U, Yakhno N, Raz I, Novosadova M, Maus J, Samigullin R. Oral treatment with alpha-lipoic acid improves symptomatic diabetic polyneuropathy: the SYDNEY 2 trial. Diabetes Care. 2006 Nov;29(11):2365-70. doi: 10.2337/dc06-1216. PMID 17065669
- BACKGROUNDCremer DR, Rabeler R, Roberts A, Lynch B. Safety evaluation of alpha-lipoic acid (ALA). Regul Toxicol Pharmacol. 2006 Oct;46(1):29-41. doi: 10.1016/j.yrtph.2006.06.004. Epub 2006 Aug 14. PMID 16904799
- BACKGROUNDSegermann J, Hotze A, Ulrich H, Rao GS. Effect of alpha-lipoic acid on the peripheral conversion of thyroxine to triiodothyronine and on serum lipid-, protein- and glucose levels. Arzneimittelforschung. 1991 Dec;41(12):1294-8. PMID 1815532
- BACKGROUNDGAL EM, RAZEVSKA DE. Studies on the in vivo metabolism of lipoic acid. 1. The fate of DL-lipoic acid-S35 in normal and thiamine-deficient rats. Arch Biochem Biophys. 1960 Aug;89:253-61. doi: 10.1016/0003-9861(60)90051-5. No abstract available.