Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Breast Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

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Micronutrients

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Paclitaxel

Albumin-Bound Paclitaxel

Thioctic Acid

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Folic Acid

Vitamin B Complex

Trace Elements

Alpha-lipoic Acid

Folate

Vitamin B9

Oral administration three times daily (morning, mid-day, night)

The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.

Alpha lipoic acid

Jeffrey A. Allen, MD

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.

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

Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.

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.

Northwestern University

Assistant Professor in Ken and Ruth Davee Department of Neurology

Oral administration three times daily (morning, mid-day, night)

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.

Alpha Lipoic Acid

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

The small number of enrolled patients precluded any meaningful ALA dose finding or neuropathy prevention efficacy statements. A formal statistical analysis of the data was not able to be performed.

Jeffrey Allen M.D.

Although our dose finding analysis suggested a maximum tolerated dose of 500mg daily, it should be noted that we failed to fully complete the Continual Reassessment Method (CRM) dose finding portion of the study. As such, we can not make confident dose finding statements on the basis of this trial.

Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile

Proportion of Patients Who Complete the Proposed Regimen of Daily ALA

Cumulative Rate of Adverse Events

The study was designed to first explore the optimal ALA dose. The baseline dose was 100 mg three times daily for four months. Dose escalation was to occur until a maximum tolerated dose (MTD) was found. Once the MTD was established we were then to enroll additional patients at the MTD for efficacy analysis. The study failed to reach the MTD. Only small numbers of patients were enrolled. As such, we were unable to perform any meaningful efficacy (TNS) analysis.

Failure to reach the MTD precluded our ability to perform any meaningful analysis of the TNS.

Spots Global Cancer Trial Database for Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy

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