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

September 26, 2014 updated by: Jeffrey Allen, Northwestern University

Dose Finding and Tolerability Study of Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Peripheral 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  1. Diagnosis of Breast cancer.

  2. Breast cancer must meet the following criteria:

    • Early stage breast cancer (stages I, IIA) must be estrogen receptor (ER) positive AND low tumor grade (histopathologic grade 1 or 2)
    • Locally advanced breast cancer (LABC) (stages IIB, IIIA, IIB as defined by the Union for International Cancer Control and American Joint Committee on Cancer) must be ER positive, HER2 positive or HER2 negative, AND satisfy the following requirements: high endocrine responsiveness (defined as greater than 50% of tumor cells staining for hormone receptors), Grade 1 or 2 histological grade, less than 4 nodes positive, absence of extensive peritumoral vascular invasion, AND pathological tumor size less than 5 cm.
    • Inflammatory breast cancer (IBC) (stage IIIC)
    • Metastatic breast cancer (stage IV)
  3. Must be receiving single agent paclitaxel in their prescribed chemotherapy regimen.
  4. Age > 18 years. There is no upper age limit for participation in this study.
  5. Required lab values: AST, ALT, creatinine
  6. Women of childbearing potential and sexually active males must agree to use contraception while on study.
  7. ECOG performance status 0,1,2
  8. All patients must have given signed, informed consent.

Exclusion Criteria

  1. Breast cancer meeting the following criteria:

    • Breast cancer stage 0
    • Early stage breast cancer (stages I, IIA) that is ER negative OR higher tumor grade (histopathologic grade greater than 2)
    • Stages I, II, and IIIA triple negative breast cancer (negative for estrogen receptors, progesterone receptors, and HER2)
    • LABC (stages IIB, IIIA, IIB) if they have low endocrine responsiveness (defined as less than 50% of tumor cells staining for hormone receptors), Grade 3 histological grade, 4 or more nodes positive, presence of extensive peritumoral vascular invasion, OR pathological tumor size greater than 5 cm
    • LABC (stages IIB, IIIA, IIB) that are ER negative
  2. Evidence of pre-existing peripheral neuropathy as determined by baseline Michigan neuropathy screening instrument score > 2.
  3. Previous chemotherapy treatment of any kind.
  4. AST and ALT >2 times upper limit of normal; Creatinine > 2.0 mg/dL.
  5. Current use of medications or substances known to be associated with peripheral neuropathy.
  6. Use of ALA or other anti-oxidant supplements during the prior three months.
  7. Diabetes mellitus or use of medications known to lower blood sugar.
  8. Participation in any other experimental trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Thioctic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Who Complete the Proposed Regimen of Daily ALA
Time Frame: 4 months
4 months
Cumulative Rate of Adverse Events
Time Frame: 4 months
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Jeffrey A. Allen, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (Estimate)

March 11, 2011

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 26, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUALA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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