Recruiting

Cancer Therapy Pain

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT00515060

Conditions

Advanced Cancer

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sensory Tests

Study Details

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

Study ID

NCT00515060

Start date

Jan 23, 2001

Status verified date

Jun, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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:

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.

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Cancer Therapy-Induced Pain

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

Interventions

Sensory Tests

Tests to find the threshold at which perceive stimuli.

Primary outcome measure

  • Participant Heat + Cold Pain Threshold [ Time Frame: 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> [ Time Frame: 1 Hour Sensory Testing: Baseline + testing at repeated intervals throughout chemotherapy or at later follow-ups. ]

Central Contacts and Locations

Central contacts

Patrick M. Dougherty, PhD

713-745-0438pdougherty@mdanderson.org

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Patrick M. Dougherty, PhD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-10.