Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer - Full Text View

Sponsors and Collaborators:	University of Medicine and Dentistry New Jersey M.D. Anderson Cancer Center Jarrow Formulas Inc
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00705029

Purpose

The purpose of this study is to find out the effects (good and bad) Alpha-Lipoic Acid (ALA) has on preventing a side effect of platinum-containing chemotherapy called peripheral neuropathy. In this study, one group of subjects will receive Alpha-Lipoic Acid (ALA) and another group will receive a placebo control pill. A placebo control pill is a "look-a-like" pill but does not have any medication in it. Another name for placebo pill is "sugar pill." Peripheral neuropathy is an abnormal, uncomfortable, often painful, sensations and feelings in hands or feet. The sensations and feelings in the hands and feet can effect the normal use of the hands and feet, such as in buttoning, writing, typing, sewing, picking up small objects, and walking.

Currently there is no standard or reliable therapy to prevent this type of neuropathy. Alpha-Lipoic Acid (ALA) is a dietary supplement that is supposed to prevent or reduce the symptoms.

Condition	Intervention	Phase
Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific	Dietary Supplement: alpha-lipoic acid Other: placebo	Phase III

MedlinePlus related topics: Cancer Dietary Supplements Diets Peripheral Nerve Disorders

Drug Information available for: Thioctic Acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

Severity of neuropathy as measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire total score at baseline and at 6-8, 12, 24, 36, and 48 weeks [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Group differences in change scores from baseline at 6-8, 12, 24, 36, and 48 weeks [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Number of courses received [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Optimal tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	244
Study Start Date:	January 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients receive oral alpha-lipoic acid* three times daily for at least 24 weeks in the absence of unacceptable toxicity.	Dietary Supplement: alpha-lipoic acid Given orally
2: Placebo Comparator Patients receive oral placebo* three times daily for at least 24 weeks in the absence of unacceptable toxicity	Other: placebo Given orally

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Scheduled to receive a cisplatin- or oxaliplatin-containing chemotherapy regimen for cancer
No established clinical neuropathy
No clinically evident CNS metastases, including leptomeningeal metastases

PATIENT CHARACTERISTICS:

AGE

Not specified PERFORMANCE STATUS
Not specified LIFE EXPECTANCY
Not specified HEMATOPOIETIC
Not specified HEPATIC
Bilirubin < 2 mg/dL RENAL
Creatinine < 2 mg/dL OR
Creatinine clearance > 45 mL/min OTHER
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Must have a normal state of arousal
No confusion or memory or concentration deficit
No history of diabetes mellitus requiring oral medication or insulin treatment
No chronic alcoholism
No other active CNS disease (e.g., dementia or encephalopathy)

PRIOR CONCURRENT THERAPY:

BIOLOGIC THERAPY

Not specified CHEMOTHERAPY
See Disease Characteristics
No carboplatin, vincristine, vinblastine, paclitaxel, or docetaxel for 6 months prior, during, and 6 months after study treatment ENDOCRINE THERAPY
Not specified RADIOTHERAPY
Not specified SURGERY
Not specified OTHER
Concurrent medications that can modify peripheral neuropathy (e.g., gabapentin, lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are allowed provided there is no dose adjustment within 2 weeks before study entry and during study participation
No concurrent vitamin E (including multivitamins that contain vitamin E) ≥ 100 IU per day
No concurrent physical modality (e.g., annodyne [monochromatic near-infrared photoenergy, 890 nm], microcurrent, or transcutaneous electrical neural stimulation) for peripheral neuropathy related symptoms unless physical or occupational therapy for functional training

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705029

Contacts

Contact: Robert Wieder, MD, PhD	9739724871	wiederro@umdnj.edu
Contact: Yasmeen Barber, BA	9739727789	barberys@umdnj.edu

Locations

United States, New Jersey
University of Medicine and Dentistry of New Jersey	Recruiting
Newark, New Jersey, United States, 07101-1709
Contact: Yasmeen S Barber, BA 973-972-7789 barberys@umdnj.edu
Sub-Investigator: Margarette Bryan, MD
Principal Investigator: Robert Wieder, MD, PhD
Sub-Investigator: Bhavesh Balar, MD

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

M.D. Anderson Cancer Center

Jarrow Formulas Inc

Investigators

Principal Investigator:

Ying Guo, MD, MS

M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	The University of Texas M. D. Anderson Cancer Center, Department of Rehabilitation Medicine ( Ying Guo, MD, MS )
Study ID Numbers:	0120070249
Study First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00705029 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vitamin B Complex
Antioxidants
Neurotoxicity Syndromes
Poisoning
Disorders of Environmental Origin
Trace Elements
Oxaliplatin

Neuromuscular Diseases
Cisplatin
Peripheral Nervous System Diseases
Vitamins
Micronutrients
Thioctic Acid

Additional relevant MeSH terms:

Antioxidants
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Neurotoxicity Syndromes
Growth Substances
Nervous System Diseases
Physiological Effects of Drugs
Poisoning

Disorders of Environmental Origin
Protective Agents
Pharmacologic Actions
Neuromuscular Diseases
Peripheral Nervous System Diseases
Vitamins
Micronutrients
Thioctic Acid

ClinicalTrials.gov processed this record on May 06, 2009