Psychophysical Studies of Cancer Therapy-Induced Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00515060
First received: August 9, 2007
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

The goal of this clinical research study is to improve understanding of the sensory qualities of patients who have pain caused by cancer therapy. This information will add to the understanding of what causes this pain and may lead to better management of the pain. The specific goal is to define the sensory capacity of patients in their area of pain as a consequence of cancer therapy compared to another body area without pain.


Condition Intervention
Advanced Cancer
Pain
Other: Sensory Tests

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Psychophysical Studies of Cancer Therapy-Induced Pain: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Participant Heat + Cold Pain Threshold [ Time Frame: 1 Hour Sensory Testing: Baseline + testing at repeated intervals throughout chemotherapy or at later follow-ups. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: January 2001
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cancer Therapy-Induced Pain
Patients with advanced cancer entering chemotherapy or have reported pain as a result of cancer treatment.
Other: Sensory Tests
Tests to find the threshold at which perceive stimuli.

Detailed Description:

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.

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.

This is an investigational study. A total of 350 patients will be enrolled in this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515060

Contacts
Contact: Patrick M. Dougherty, PhD 713-745-0438

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Patrick M. Dougherty, PhD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Patrick M. Dougherty, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00515060     History of Changes
Other Study ID Numbers: ANS00-339
Study First Received: August 9, 2007
Last Updated: October 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Therapy-Induced Pain
Pain Threshold
Sensory Tests
Stimuli
Pain

ClinicalTrials.gov processed this record on October 16, 2014