NCT00112996

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2005

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

7.3 years

First QC Date

June 2, 2005

Last Update Submit

April 7, 2014

Conditions

NeurotoxicityUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

neurotoxicityunspecified adult solid tumor, protocol specificunspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Severity of neuropathy

    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

    Up to 48 weeks

Secondary Outcomes (3)

  • Group Differences in Change scores

    Up to 48 weeks

  • Number of courses received

    Up 48 weeks

  • Optimal tumor response

    Up to 48 weeks

Study Arms (2)

Arm I: Alpha-Lipoic Acid

EXPERIMENTAL

Oral alpha-lipoic acid three times daily for at least 24 weeks in the absence of unacceptable toxicity.

Drug: alpha-lipoic acid

Arm II: Placebo

PLACEBO COMPARATOR

Oral placebo three times daily for at least 24 weeks in the absence of unacceptable toxicity.

Other: placebo

Interventions

alpha-lipoic acidDRUG

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 I: Alpha-Lipoic Acid
placeboOTHER

Given orally two similar color and sized placebo control tablets three times a day continued for 24 weeks.

Arm II: Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, 72913, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Cabrini Center for Cancer Care at Christus St. Frances Cabrini Hospital

Alexandria, Louisiana, 71301, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Cancer Research for the Ozarks

Springfield, Missouri, 65804, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

CCOP - Main Line Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

University of Texas M.D. Anderson CCOP Research Base

Houston, Texas, 77030-4009, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Related Links

MeSH Terms

Conditions

Neurotoxicity Syndromes

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Nervous System DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Ying Guo, MD, MS

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2005

First Posted

June 3, 2005

Study Start

January 1, 2007

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

US(13)