Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Newark, New Jersey 07101


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.


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


NCT ID:

NCT00705029


Primary Contact:

Principal Investigator
Ying Guo, MD, MS
M.D. Anderson Cancer Center

Robert Wieder, MD, PhD
Phone: 9739724871
Email: wiederro@umdnj.edu


Backup Contact:

Email: barberys@umdnj.edu
Yasmeen Barber, BA
Phone: 9739727789


Location Contact:

Newark, New Jersey 07101
United States

Yasmeen S Barber, BA
Phone: 973-972-7789
Email: barberys@umdnj.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.