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NCT Number: NCT00515060

Psychophysical Studies of Cancer Therapy Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Patrick M. Dougherty, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • The subjects must be able to understand the nature of the study and have signed consent.
  • 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
  • (For Healthy Controls) Willing to participate and have signed an informed consent.

Exclusion criteria

  • Patients who refuse to participate or who are determined incapable of completing the research.
  • (For Healthy Controls) Receiving anti-coagulants, immunosuppressed or diabetic.

Treatment and study plan

Sensory Tests

Other

Tests to find the threshold at which perceive stimuli.

Primary outcomes

  1. Participant Heat + Cold Pain Threshold

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

  2. Participant Mechanical Testing Results <Touch Detection Threshold; Sharpness Threshold + Pain Ratings to Needle Probe; Bump Test>

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

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick M. Dougherty, PhD

CONTACT

[email protected]

713-745-0438

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2028
Study completion
2028
First posted
Aug 13, 2007
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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