Psychophysical Studies of Cancer Therapy Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who refuse to participate or who are determined incapable of completing the research.
(For Healthy Controls) Receiving anti-coagulants, immunosuppressed or diabetic.
Trial population
Patients, 18 years or older, with advanced cancer experiencing cancer therapy-induced pain.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Sensory Tests
Other interventionTests to find the threshold at which perceive stimuli.
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: Cancer Therapy-Induced Pain1 intervention
Trial outcomes
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.Sponsors and contacts
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Source ClinicalTrials.gov