NCT01313117

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Alpha lipoic acid	The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-08-01
• Completion: 2014-01-01
• First posted: 2011-03-11
• Last updated: 2014-10-02
• Results posted: 2014-10-02

Locations

1 site across 1 country: United States