Ensayos clínicos

Inclusion Criteria:

Scheduled to undergo treatment with TAXOL at 150-200 mg/m2 and CBDCA at area under the curve (AUC) = 5-7 every 21 or 28 days for at least 12 weeks; alternatively, paclitaxel can be prescribed at 80 mg/m2 weekly for at least 12 weeks, with the same CBDCA dose of AUC = 5-7 every 21 days; additional chemotherapy agents are allowed (bevacizumab, etoposide, etc) per physician discretion, as long as they are not known to be neurotoxic; Note: patients ideally will begin GSH therapy prior to their first dose of this chemotherapy, but must begin GSH therapy prior to their second dose of chemotherapy

• Ability to sign informed consent and understand the nature of a placebo-controlled trial
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Ability to complete English language questionnaire(s) by themselves or with assistance
• Life expectancy ≥ 6 months
• Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only, per clinician discretion
• Willingness to provide blood specimens as required by the protocol
• White blood cell (WBC) ≥ 3400
• Absolute neutrophil count (ANC) ≥ 1500
• Platelet (PLT) ≥ 100,000
• Hemoglobin (HgB) > 10.0
• Creatinine ≤ 1.5 x upper limit of normal (ULN)

Exclusion Criteria:

• Pre-existing history of peripheral neuropathy > grade 1 (National Cancer Institute [NCI] CTCAE version [v] 4.0) due to any cause (e.g., chemotherapy, diabetes, alcohol, toxin, or heredity)
• Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient

• Any of the following:

  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception
• Prior TAXOL and/or CBDCA chemotherapy treatment (other than the current treatment regimen)

• Concurrent use of any agent being used specifically to prevent or treat neuropathy, including but not limited to the following:

  • Gabapentin
  • Glutamine powder or glutamine tablets
  • Vitamin B6 or E