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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jeffrey Allen, Northwestern University
ClinicalTrials.gov Identifier:
NCT01313117
First received: March 9, 2011
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Peripheral Neuropathy
Drug: Alpha lipoic acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Identification of the optimal dose of ALA based on acceptable adverse event(AE) profile [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    based on acceptable adverse event (AE) profile


Secondary Outcome Measures:
  • Proportion of patients who complete the proposed regimen of daily ALA [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Cumulative rate of adverse events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Total neuropathy score (TNS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313117

Contacts
Contact: Sabeeha R. Mukit, MBBS,MS 312-503-6868 s-mukit@northwestern.edu
Contact: Patricia Casey, OTR 312-695-0774 pcasey1@nmff.org

Locations
United States, Illinois
Northwestern Medical Faculty Foundation Recruiting
Chicago, Illinois, United States, 60611
Contact: Sabeeha R. Mukit, MBBS,MS    312-503-6868    s-mukit@northwestern.edu   
Principal Investigator: Jeffrey A. Allen, MD         
Sub-Investigator: Robert Sufit, MD         
Sub-Investigator: Jeffrey Raizer, MD         
Sub-Investigator: William Gradishar, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jeffrey A. Allen, MD Northwestern University
  More Information

Additional Information:
Publications:

Responsible Party: Jeffrey Allen, Assistant Professor in Ken and Ruth Davee Department of Neurology, Northwestern University
ClinicalTrials.gov Identifier: NCT01313117     History of Changes
Other Study ID Numbers: NUALA-01, STU00041525
Study First Received: March 9, 2011
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
chemotherapy
peripheral neuropathy
paclitaxel
breast cancer

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Paclitaxel
Thioctic Acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 18, 2014