MDACC Study Summary ANS00-339

Study Summary
No. ANS00-339:.......Breast; Gastrointestinal; Leukemia; Lung; Myeloma; Pain......Patrick M. Dougherty......Anesthesiology

Study Summary Title



Study Summary Number:	ANS00-339

Study Title:	Psychophysical Studies of Cancer Therapy-Induced Pain: A Feasibility Study

Physician

New Patient Referral



Name:	Patrick M. Dougherty	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Anesthesiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0438 Contact us about clinical trials

General Information



Disease Group:	Breast Gastrointestinal Leukemia Lung Myeloma Pain	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Chronic pain patients will have a baseline test. Patients entering chemotherapy will be tested just prior to each round of chemotherapy. All patients will be asked to have additional testing done when they return for follow-up appointments.

Treatment Agents:	Carboplatin Cisplatin Oxaliplatin PS-341 Taxol Thalidomide Vincristine	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	There is no hospitalization related to this protocol.

Description/
Intervention:

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.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	01/23/2001

Study Type:

Recruitment Status:	Open

Projected Accrual:	270

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00515060
Study Information on Clinical Trials Registry (clinicaltrials.gov)