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

Not Recruiting

Trial ID: NCT03206216


This clinical trial studies how well Diode laser fiber type Selective Stimulator (DLss) works in predicting pain development in patients with ovarian cancer who are receiving chemotherapy. Stimulating of the pain nerve fibers in the skin with 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 (CIPN).

Official Title

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

Stanford Investigator(s)

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.

Mary Lake Polan Professor

Seema Nagpal, MD
Seema Nagpal, MD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery



   - Pathologically-proven ovarian cancer, or cancer of mullerian origin, that was or will
   be treated with a 1st-line taxane plus a platinum-based chemotherapy regimen.

   - GROUP A (painful neuropathy group): Subjective symptoms of painful peripheral
   neuropathy (burning, stabbing, throbbing, painful tingling, aching in the fingers
   and/or toes) that is greater than or equal to 10 on a scale of 0 to 100 in the
   neuropathic pain questionnaire

   - GROUP B (painless neuropathy group): Subjective symptoms of painless neuropathy (loss
   of sensation, worsening balance, strange sensation in fingers and/or toes) or no
   complaints related to neuropathy.

   - Life expectancy of 6 months

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


   - Received prior chemotherapy for ovarian cancer or cancer of mullerian origin other
   than 1st-line treatment with a taxane + platinum based regimen.

   - No concurrent investigational drugs.

   - Received investigational drugs suspected to cause peripheral neuropathy.

   - History of B12 deficiency

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

   - Prior treatment for other cancers that included drugs known to cause neuropathy
   (including but are not limited to vinca-alkaloids, platinums, taxanes, bortizomib).

   - Known peripheral vascular disease

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

   - Pain rated 50 or higher on a scale of 0 to 100, with 0 = no pain at all and 100 =
   worst pain imaginable.

   - Pregnant or nursing

   - HIV-positive

   - Do not speak or read English


diagnostic test: Diode Laser fiber type Selective Stimulator (DLss)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mark Santos

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