Expired Study
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Springfield, Missouri 65804


Purpose:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as alpha-lipoic acid, may protect normal cells from the side effects of chemotherapy. Alpha-lipoic acid may also prevent damage to nerves that carry information to and from the brain and spinal cord to the rest of the body. It is not known whether alpha-lipoic acid is more effective than placebo in preventing peripheral neuropathy. PURPOSE: This randomized phase III trial is studying alpha-lipoic acid to see how well it works compared to placebo in preventing peripheral neuropathy in patients receiving chemotherapy for cancer.


Study summary:

OBJECTIVES: Primary - Compare whether treatment with alpha-lipoic acid vs placebo decreases the severity and frequency of peripheral neuropathy in cancer patients receiving a cisplatin- or oxaliplatin-containing chemotherapy regimen. - Compare the protective effect duration of these drugs in these patients. Secondary - Determine large sensory fiber integrity associated with platinum-induced peripheral neuropathy, as measured by three timed functional tests comprising fastening 6-buttons, walking 50 feet, and placing coins in a cup, in patients treated with these drugs. - Compare the number of chemotherapy courses and doses received by patients treated with these drugs. Tertiary - Compare the optimal tumor response (disease progression, stable disease, partial response, or complete response) to chemotherapy in patients treated with these drugs. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior platinum-containing treatment (yes vs no). Patients who received prior treatment are further stratified according to prior cumulative platinum exposure (cisplatin < 200 mg/m^2 or oxaliplatin < 750 mg/m^2 vs cisplatin 200-399 mg/m^2 or oxaliplatin 750-999 mg/m^2 vs cisplatin >400 mg/m^2 or oxaliplatin > 1,000 mg/m^2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral alpha-lipoic acid* three times daily for at least 24 weeks in the absence of unacceptable toxicity. - Arm II: Patients receive oral placebo* three times daily for at least 24 weeks in the absence of unacceptable toxicity. NOTE: *In both arms, patients begin taking study drug 4 days after completion of each chemotherapy treatment and continue taking study drug until 2 days before their next scheduled chemotherapy treatment. Patients' symptoms of peripheral neuropathy, pain, and functional tests are assessed at baseline and then at weeks 6-8, 12, 24, 36, and 48. PROJECTED ACCRUAL: A total of 244 patients (122 per treatment arm) will be accrued for this study within 2 years.


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 central nervous system (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., anodyne [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


Study is Available At:


Original ID:

CDR0000403155


NCT ID:

NCT00112996


Secondary ID:

MDA-CCC-0327


Study Acronym:


Brief Title:

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


Official Title:

Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

244


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:January 2007
Completion Date:April 2014
Completion Type:Actual
Primary Completion Date:April 2014
Primary Completion Type:Actual
Verification Date:April 2014
Last Changed Date:April 7, 2014
First Received Date:June 2, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Optimal tumor response
Time Frame:Up to 48 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of courses received
Time Frame:Up 48 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Group Differences in Change scores
Time Frame:Up to 48 weeks
Safety Issues:False
Description:Group differences in change scores from baseline at 6-8, 12, 24, 36, and 48 weeks
Outcome Type:Primary Outcome
Measure:Severity of neuropathy
Time Frame:Up to 48 weeks
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:alpha-lipoic acid
Description:Oral two 300 mg ALA sustained release tablets initiated 4 days after last dose of platinum and discontinued 2 days before next scheduled platinum dose, continued for 24 weeks.
Arm Name:Arm I: Alpha-Lipoic Acid
Intervention Type:Other
Name:placebo
Description:Given orally two similar color and sized placebo control tablets three times a day continued for 24 weeks.
Arm Name:Arm II: Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Arm I: Alpha-Lipoic Acid
Description:Oral alpha-lipoic acid three times daily for at least 24 weeks in the absence of unacceptable toxicity.
Study Arm Type:Placebo Comparator
Arm Name:Arm II: Placebo
Description:Oral placebo three times daily for at least 24 weeks in the absence of unacceptable toxicity.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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