Trial Search Results

Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN

This clinical trial studies how well Diode laser fiber type selective stimulator works in predicting pain development in patients with ovarian cancer who are receiving chemotherapy. Stimulating of the pain nerve fibers in your skin with an investigational device using laser light stimulation may help to predict whether a patient will develop painful peripheral neuropathy, correlate with the severity of neuropathy during and after chemotherapy treatment, and may help to explain the mechanisms of chemotherapy induced neuropathic pain.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Diagnostic Test: Peripheral Nerve Stimulation
  • Other: Questionnaire Administration

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Have pathologically proven ovarian cancer that requires first-line treatment with a
   taxane + platinum based chemotherapy regimen

   - GROUP A (painful neuropathy group): Must have subjective symptoms of painful
   peripheral neuropathy (burning, stabbing, throbbing, painful tingling, aching in the
   fingers and/or toes)

   - GROUP B (no pain group): Must either have subjective symptoms of painless neuropathy
   (loss of sensation, worsening balance, strange sensation in fingers and/or toes) or no
   complaints related to neuropathy

   - Have a life expectancy of 6 months

   - Ability to understand the study protocol, participate in testing, and the willingness
   to sign a written informed consent document

Exclusion Criteria:

   - Has received systemic chemotherapy for ovarian cancer other than first-line treatment
   with a taxane + platinum based chemotherapy regimen

   - Has received investigational drugs suspected to cause peripheral neuropathy; no
   concurrent investigational drugs may be used

   - Has a history of:

      - Neuropathy or numbness/tingling suspicious for neuropathy prior to the first dose
      of chemotherapy for ovarian cancer

      - History of prior treatment for other cancers that includes drugs known to cause
      neuropathy; these drugs include but are not limited to vinca-alkaloids,
      platinums, taxanes, bortezomib.

      - B12 deficiency

      - Known peripheral vascular disease

      - Chronic daily headache or headache more than 14 days of the month

   - Has pain rated 50 or higher on a scale of 0-100, with 0 = no pain at all and 100 =
   worst pain imaginable before the first DLss test

   - Known pregnant or nursing patients

   - Cancer survivors who have previous exposure to medications or chemotherapy that cause
   neuropathy are excluded from this study

   - Patients who are known to be human immunodeficiency virus (HIV)-positive will be
   excluded as highly active antiretroviral therapy (HAART) and HIV itself are known to
   cause peripheral neuropathy

   - Patients who do not speak or read English are excluded from this study

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mark Santos
650-498-5189
Recruiting