Psychophysical Studies of Cancer Therapy Pain



Status:Recruiting
Conditions:Cancer, Chronic Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:January 2001
End Date:January 2020
Contact:Patrick M. Dougherty, PhD
Phone:713-745-0438

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Psychophysical Studies of Cancer Therapy-Induced Pain: A Feasibility Study

The Aim of this Study is to examine the feasibility of using quantitative sensory testing
procedures, widely applied to the experimental study of sensory processing in humans both
with and without various pain syndromes, to now characterize the psychophysical properties of
neuropathic pain that has developed as a consequence of cancer therapy. Skin punch biopsies
will be performed in patients with chemotherapy-induced pain to determine whether the
impairment of nerve function is due to actual retraction or loss of innervation to the skin
in areas affected by sensory disturbance.

Study Participation:

Participants will be contacted either before their initiation of chemotherapy or following
their referral to pain management service for neuropathic cancer treatment-related pain.

The sensory tests will take about 1 hour to complete. These tests will seek to find the
threshold (a measure of sensitivity) at which you perceive stimuli, such as touch, coolness,
warmth, hot/cold feeling and pinprick. You will be asked to rate the intensity of each of
these stimuli that you perceive to be painful. You will also be asked to rate the intensity
of stimuli that are at a fixed intensity above the pain threshold for most people. Your skin
temperature using a radiometer, a scan of your fingers and/or toes, grooved peg board, a
timed task to place pegs in slots, and pain scale rating will be collected. Each part of the
sensory test are optional and will be collected when possible.

You may either be tested at repeated intervals throughout your chemotherapy or at later
follow-up dates to check the length of symptoms.

Length of Study:

Your participation will be complete once you have completed all the sensory testing.

Healthy Controls:

Study Participation:

If you agree to take part in this study, you will take part in sensory tests. The sensory
tests will take about 1 hour to complete. These tests will seek to find the threshold (a
measure of sensitivity) at which you perceive stimuli, such as touch, coolness, warmth,
hot/cold feeling and pinprick. You will be asked to rate the intensity of each of these
stimuli that you perceive to be painful. You will also be asked to rate how severe the
stimuli that are above the level considered painful by most people. Your skin temperature
using a radiometer, a scan of your fingers and/or toes, grooved peg board, a timed task to
place pegs in slots, and pain scale rating will be collected. Each part of the sensory test
are optional and will be collected when possible.

A skin biopsy will also be performed. If you are taking anticoagulants (blood thinners), you
may be asked to stop taking them for several days, before the procedure, due to the risk of
bleeding. For the skin punch biopsy, the skin is numbed with lidocaine and cleaned with
betadine and an alcohol swab. Once the skin is anesthetized (numb), a small amount of skin
will be collected using a sterile 3 mm punch tool (knife). After removal of the skin, the
area where you were tested will be wiped with a sterile gauze, and antibiotic ointment will
be applied. Then, it will be covered with a band aid. You will be given a small supply of
antibiotic ointment and band aids. You will be asked to clean the skin with soap and water
twice each day and to apply the ointment and band aid.

Researchers will study the skin sample and compare it to skin samples from cancer patients,
so that they can try to better understand the cause of pain that occurs because of cancer
therapy.

Length of Study:

Your participation will be complete once you have completed the sensory testing and skin
biopsy.

Inclusion Criteria:

1. Since moderate pain, albeit brief, will be induced, this feasibility project will be
limited to consenting adults, 18 years old or older, in which there is also a well
established QST database.

2. The subjects must be able to understand the nature of the study and have signed
consent.

3. The patients must either: a) have pain that has developed as a consequence of cancer
therapy with either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based
compounds or ionizing irradiation. OR b) have no pain that has developed as a
consequence of cancer therapy, and are just entering chemotherapy with taxanes, vinka
alkaloids, bortezomib, thalidomide, or platinum-based compounds

4. (For Healthy Controls) Willing to participate and have signed an informed consent.

Exclusion Criteria:

1. Patients who refuse to participate or who are determined incapable of completing the
research.

2. (For Healthy Controls) Receiving anti-coagulants, immunosuppressed or diabetic.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Patrick M. Dougherty, PhD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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