Psychophysical Studies of Cancer Therapy Pain

NCT00515060 | Recruiting

• 1 other identifier: ANS00-339
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer; Pain

Keywords

Advanced Cancer; Therapy-Induced Pain; Pain Threshold; Sensory Tests; Stimuli; Pain

Outcome Measures

Primary Outcomes (2)

• Participant Heat + Cold Pain Threshold

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

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

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

Study Arms (1)

Cancer Therapy-Induced Pain

Patients with advanced cancer entering chemotherapy or have reported pain as a result of cancer treatment.

Other: Sensory Tests

Interventions

Sensory Tests OTHER

Tests to find the threshold at which perceive stimuli.

Cancer Therapy-Induced Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients, 18 years or older, with advanced cancer experiencing cancer therapy-induced pain.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick M. Dougherty, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick M. Dougherty, PhD

CONTACT

713-745-0438; pdougherty@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: January 23, 2001
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)