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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile
Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.
Time frame: 4 months
Proportion of Patients Who Complete the Proposed Regimen of Daily ALA
Time frame: 4 months
Cumulative Rate of Adverse Events
Time frame: 4 months
Total Neuropathy Score (TNS)
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.
Time frame: 4 months
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