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


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer, Pain

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Trial Information

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


Cancer Patient 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.

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.

This is an investigational study. A total of 270 patients will be enrolled in this study.
All will be enrolled at M. D. Anderson.

Study Participation (Healthy Participant):

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.

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.

This is an investigational study. A total of 20 healthy control participants will be
enrolled in this study. All will be enrolled at M. D. Anderson.


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 moderate to severe pain due to cancer therapy with
vinca alkaloids, taxanes, bortezomib, platinum based compounds or ionizing
irradiation. b) be pain free but just entering chemotherapy with taxanes,
vincristine, 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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Participant Heat + Cold Pain Threshold

Outcome Time Frame:

1 Hour Sensory Testing: Baseline + testing at repeated intervals throughout chemotherapy or at later follow-ups.

Safety Issue:

No

Principal Investigator

Patrick M. Dougherty, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ANS00-339

NCT ID:

NCT00515060

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Advanced Cancer
  • Pain
  • Advanced Cancer
  • Therapy-Induced Pain
  • Pain Threshold
  • Sensory Tests
  • Stimuli
  • Pain
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030