Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose Finding and Tolerability Study of Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Peripheral Neuropathy|
- Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.
- Proportion of Patients Who Complete the Proposed Regimen of Daily ALA [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Cumulative Rate of Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Total Neuropathy Score (TNS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]The Total Neuropathy score (TNS) is a validated score that combines signs, symptoms, and very limited nerve conduction studies (NCS). It was designed to assess peripheral nerve function and has been used as an endpoint in clinical trials of toxic neuropathy. The TNS is a composite scale with a range of values from 0 (normal) to 28 (severely affected). It includes data from 7 different categories. Patients are asked to assess the severity of sensory symptoms on a scale of 0 (no symptoms) to 4 (symptoms above knees or elbows, or functionally disabling). Next, 4 examination categories are assessed. These include pin sensation, vibration sensation, deep tendon reflexes, and strength. Signs are scored from 0 to 4 depending on severity. The nerve conduction portion of the scale consists of measurements of a motor (peroneal) and sensory (sural) nerve. Motor and sensory responses are graded on a scale of 0 to 4 depending on the severity of an abnormality.
|Study Start Date:||February 2012|
|Study Completion Date:||January 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Alpha lipoic acid
Oral administration three times daily (morning, mid-day, night)
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.
Other Name: Thioctic Acid
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313117
|United States, Illinois|
|Northwestern Medical Faculty Foundation|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Jeffrey A. Allen, MD||Northwestern University|