Clinical trial · Interventional
Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer
Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as alpha-lipoic acid, may protect normal cells from the side effects of chemotherapy. Alpha-lipoic acid may also prevent damage to nerves that carry information to and from the brain and spinal cord to the rest of the body. It is not known whether alpha-lipoic acid is more effective than placebo in preventing peripheral neuropathy. PURPOSE: This randomized phase III trial is studying alpha-lipoic acid to see how well it works compared to placebo in preventing peripheral neuropathy in patients receiving chemotherapy for cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurotoxicity | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alpha-lipoic acid | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: Alpha-Lipoic Acid
- description
- Oral alpha-lipoic acid three times daily for at least 24 weeks in the absence of unacceptable toxicity.
- interventionNames
- Drug: alpha-lipoic acid
- type
- PLACEBO_COMPARATOR
- label
- Arm II: Placebo
- description
- Oral placebo three times daily for at least 24 weeks in the absence of unacceptable toxicity.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Severity of neuropathy
- timeFrame
- Up to 48 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Scheduled to receive a cisplatin- or oxaliplatin-containing chemotherapy regimen for cancer * No established clinical neuropathy * No clinically evident CNS metastases, including leptomeningeal metastases PATIENT CHARACTERISTICS: Age * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin \< 2 mg/dL Renal * Creatinine \< 2 mg/dL OR * Creatinine clearance \> 45 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must have a normal state of arousal * No confusion or memory or concentration deficit * No history of diabetes mellitus requiring oral medication or insulin treatment * No chronic alcoholism * No other active central nervous system (CNS) disease (e.g., dementia or encephalopathy) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No carboplatin, vincristine, vinblastine, paclitaxel, or docetaxel for 6 months prior, during, and 6 months after study treatment Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Concurrent medications that can modify peripheral neuropathy (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are allowed provided there is no dose adjustment within 2 weeks before study entry and during study participation * No concurrent vitamin E (including multivitamins that contain vitamin E) ≥ 100 IU per day * No concurrent physical modality (e.g., anodyne \[monochromatic near-infrared photoenergy, 890 nm\], microcurrent, or transcutaneous electrical neural stimulation) for peripheral neuropathy related symptoms unless physical or occupational therapy for functional training
References
Publications (0)
Data not yet available