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Study Summary
No. 2004-0728:.......Cancer Prevention; Pain......Ying Guo......Palliative Care & Rehabilitation Medicine
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Study Summary Title
Study Summary
Number:
2004-0728
Study Title:PREVENTION OF CISPLATIN- OR OXALIPLATIN-INDUCED PERIPHERAL NEUROPATHY WITH ALPHA-LIPOIC ACID: A PLACEBO-CONTROLLED PHASE III TRIAL
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Physician New Patient Referral
Name:Ying GuoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Palliative Care & Rehabilitation MedicineReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-2327
Contact us about clinical trials
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General Information
Disease Group:Cancer Prevention
Pain
Supported By:N/A
Phase of Study:Phase IIIReturn
Visit:
Study visits are based on the patient's assigned chemotherapy regimen, regimens
vary.
Treatment
Agents:
Alpha-Lipoic Acid
Cisplatin
Oxaliplatin
Home Care:N/A
Treatment Loc:MDACC + Community Programs (CCOP/Network)
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to test the effects (good and bad)
of alpha-lipoic acid (ALA) in preventing peripheral neuropathy (abnormal,
uncomfortable, often painful, sensations and feelings in hands or feet) caused
by chemotherapy, as compared to the effect of a placebo. Researchers want to
find out if this dietary supplement can help to decrease the symptoms as well.
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Study Objectives / Outcomes
Primary
1. To determine if treatment with á-lipoic acid (ALA, thioctic acid) treatment can decrease the severity and frequency of peripheral neuropathy after 24 weeks of chemotherapy that includes cisplatin or oxaliplatin, as measured by the FACT GOG-NTX scale and compared to placebo-treated control patients.

2. To determine if the protective effect of ALA vs. placebo on platinum-induced peripheralneuropathy lasts for an additional 12 and 24 weeks (beyond the first 24 weeks), whether or not the platinum therapy is continued.

Secondary

1. To assess large sensory fiber integrity associated with platinum induced peripheral neuropathy, as measured by three timed functional tests: fastening 6-buttons, walking 50 feet, and placing coins in a cup.

2.
To determine if the number of chemotherapy cycles and doses received by patients in the ALA group is more than those received by patients in the placebo group.

Tertiary

      To assess the optimal tumor response to chemotherapy prior to 24 weeks in the ALA group vs. placebo group, which will fall into 4 catagories: PD- progressive disease, SD-stable disease, PR-partial response, CR-complete response.
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Study Status Information
Study Activation / Registration Date:01/03/2007
IRB Review and Approval Date:04/06/2005
Study Type:Phase Iii
Recruitment Status:Terminated
Projected Accrual:244
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients, or the legal guardians of patients, must have the ability to understand and willingness to sign a written informed consent document.

2) The patient's scheduled chemotherapy must contain cisplatin or oxaliplatin. If a patient is in the process of receiving platinum containing chemotherapy, the cumulative dose of platinum prior to randomization will be used for stratification. The dose of platinum received after the randomization will be used to calculate how many cycles and doses the patient received during the trial.

3) Patients must be able to have a normal state of arousal and be generally devoid of confusion, memory or concentration deficit at the time of specified baseline and treatment evaluations.

4) Moderately normal liver and renal function, as determined by serum bilirubin <2 mg/dL and creatinine <2 mg/dL or calculated creatinine clearance >45 ml/min.

5) Female patients must agree to use contraception if in child bearing years. Acceptable forms of contraception include: continuous abstinence, Depo-Provera shot, tubal ligation, NuvaRing vaginal ring, Ortho Evra skin patch, oral contraceptive, IUD-Mirena, vasectomy, male condom, diaphragm.

Exclusion Criteria:1) Patients who decline to participate or who are determined incapable of completing the research.

2) Carboplatin, vincristine, vinblastine, paclitaxel, or docetaxel within the past 6 months or planned in the next 12 months.

3) Patients with established clinical neuropathy.

4) Patients with a history of diabetes mellitus requiring oral medication or insulin treatment.

5) Patients with chronic alcoholism, as clinically estimated by the patient's physician.

6) Patients who are on medication (for whatever reason) that can modify peripheral neuropathy (gabapentin, lamotrigine, carbamazepine, phenytoin, tricyclic antidepressants, etc) and had dose adjustment within the 2 weeks prior to starting the current trial or plan to have adjustment of these medications during trial. The intent is to minimize the chance that success or failure of the ALA is due to changes in other therapies with a potential anti-neuropathy effect.

7) Active CNS disease, such as clinically-evident metastases (any mets in the CNS) or leptomeningeal disease, dementia, or encephalopathy.

8) Patients receiving greater than 100 IU of vitamin E (including multi-vitamins that contain greater than 100 IU of vitamin E). Since vitamin E is a known antioxidant, consuming high doses of vitamin E may obscure the conclusion of this study. Note: Patients who decide to discontinue vitamin E or multi–vitamins with vitamin E may participate in this trial. No lapse in time is required from the time vitamin E is discontinued to time of enrollment to trial.

9) Patients who are pregnant.

10) Patients who receive physical modality including: Annodyne(monochromatic near-infrared photoenergy,890 nm), microcurrent, or transcutaneous electrical neural stimulation for peripheral neuropathy related symptoms during the trial. ( Patient is allowed to receive physical or occupational therapy treatment for functional training).

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Links
Registration Number: NCT00112996
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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