Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy
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|ClinicalTrials.gov Identifier: NCT01313117|
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : October 2, 2014
Last Update Posted : October 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Neuropathy||Drug: Alpha lipoic acid||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose Finding and Tolerability Study of Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Peripheral Neuropathy|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||January 2014|
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
- Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile [ Time Frame: 4 months ]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 ]
- Cumulative Rate of Adverse Events [ Time Frame: 4 months ]
- Total Neuropathy Score (TNS) [ Time Frame: 4 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313117
|United States, Illinois|
|Northwestern Medical Faculty Foundation|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Jeffrey A. Allen, MD||Northwestern University|