Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2001-01-23
2028-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Cancer Therapy-Induced Pain
Patients with advanced cancer entering chemotherapy or have reported pain as a result of cancer treatment.
Sensory Tests
Tests to find the threshold at which perceive stimuli.
Interventions
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Sensory Tests
Tests to find the threshold at which perceive stimuli.
Eligibility Criteria
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Inclusion Criteria
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
2. (For Healthy Controls) Receiving anti-coagulants, immunosuppressed or diabetic.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Patrick M. Dougherty, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Related Links
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The University of Texas M.D.Anderson Cancer Center
Other Identifiers
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ANS00-339
Identifier Type: -
Identifier Source: org_study_id