Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy

Phase 1

Completed

• Conditions: Peripheral Neuropathy
• Interventions: Drug: Alpha lipoic acid

• Registration Number: NCT01313117
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-11
• Study Start: 2012-02
• Primary Completion: 2013-08
• Study Completion: 2014-01
• Status Verified: 2014-09
• Results First Submitted: 2014-09-20
• Results First Submitted QC: 2014-09-26
• Last Update Submitted: 2014-09-26
• Results First Posted: 2014-10-02
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alpha lipoic acid	Alpha lipoic acid	Oral administration three times daily (morning, mid-day, night)

Primary Outcome Measures

Name	Time	Method
Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile	4 months	Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Who Complete the Proposed Regimen of Daily ALA	4 months
Cumulative Rate of Adverse Events	4 months
Total Neuropathy Score (TNS)	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.

Trial Locations

Locations (1)

Northwestern Medical Faculty Foundation; 🇺🇸 Chicago, Illinois, United States