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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313117
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Information provided by (Responsible Party):
Jeffrey Allen, 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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Drug: Alpha lipoic acid Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

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 Name: Thioctic Acid

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Proportion of Patients Who Complete the Proposed Regimen of Daily ALA [ Time Frame: 4 months ]
  2. Cumulative Rate of Adverse Events [ Time Frame: 4 months ]
  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01313117

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United States, Illinois
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Jeffrey A. Allen, MD Northwestern University

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Responsible Party: Jeffrey Allen, Assistant Professor in Ken and Ruth Davee Department of Neurology, Northwestern University Identifier: NCT01313117    
Other Study ID Numbers: NUALA-01
First Posted: March 11, 2011    Key Record Dates
Results First Posted: October 2, 2014
Last Update Posted: October 2, 2014
Last Verified: September 2014
Keywords provided by Jeffrey Allen, Northwestern University:
peripheral neuropathy
breast cancer
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances