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

Laser stimulation, similar to what is being used in the DLss, has been used in pain clinics
and research since 1975 as a diagnostic test for pain sensitivity. It is widely considered to
be both useful and safe. Laser irradiation /stimulation simultaneously can activate either
the heat-sensitive A-delta or C never fibers, with the difference in affected nerves being
primarily on the basis of different pulse duration and different diameter of the simulation
target. The laser for both type of simulation is set to 980 nanometers.

Laser irradiation intensity is measured as the milli-amperes (mA) required to generate that
laser intensity. The pain sensitively of A-delta and C fibers are assessed by specific
protocols (A-delta protocol: 60 millisecond duration, 980 nm stimuli, 1 mm diameter
simulation target. C protocol: 2 second duration, 5 mm diameter simulation target).

Pain sensitivity is assessed as the ratio of painful laser intensity between the A-delta and
C fibers (A-delta:C pain ratio).

Participants with ovarian cancer, with either painful (Group A) or painless (Group B)
chemotherapy-induced peripheral neuropathy (CIPN), were to be assessed for pain sensitivity
after 9 and 21 weeks of chemotherapy with Diode Laser fiber type Selective Stimulator (DLss).
Both painful or painless CIPN are undesirable chemotherapy-induced side effects. The same
testing protocol was used for these groups (ie, any difference between the groups would be
attributed to differences in pain sensitivity between the groups). Patients would report the
stimulation on a 0 to 100 scale, with 0 = no sensation; 10 = definite sensation; 0 to 40 =
"painful"; and 100 = worst imaginable pain.

PRIMARY OBJECTIVES:

- Determine if there is a difference in the A-delta:C pain threshold ratio for patients
with painful chemotherapy-induced peripheral neuropathy (CIPN) compared to patients with
painless CIPN.

- Determine the A-delta:C ratio over time in patients with CIPN.

INCLUSION CRITERIA

- 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.

EXCLUSION CRITERIA

- 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