Know Cancer

or
forgot password

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


Phase 3
N/A
N/A
Open (Enrolling)
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ying Guo, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

0120070249

NCT ID:

NCT00705029

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Neurotoxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Peripheral Nervous System Diseases
  • Neurotoxicity Syndromes

Name

Location

University of Medicine and Dentistry of New JerseyNewark, New Jersey  07103-2425