MDACC Study Summary 2010-0675

Study Summary
No. 2010-0675:.......Pain......Lorenzo Cohen......Behavioral Science

Study Summary Title



Study Summary Number:	2010-0675

Study Title:	Effects of Neurofeedback on Neural Function, Neuromodulation, and Chemotherapy-Induced Neuropathic Pain

Physician

New Patient Referral



Name:	Lorenzo Cohen	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-745-4260 Contact us about clinical trials

General Information



Disease Group:	Pain	Supported By:	N/A

Phase of Study:	Phase 0	Return Visit:

Treatment Agents:	Behavioral intervention	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this study is to learn if using a non-invasive therapy called "neurofeedback training" can help teach patients ways to modify their own brain waves to decrease the perception of pain and improve quality of life.

Study Objectives / Outcomes

The proposed trial will examine the effectiveness of a personalized treatment approach to managing chemotherapy-induced neuropathic cancer pain via electroencephalogram (EEG) biofeedback.

Primary Objective
1. Test the effects of an individualized electroencephalogram (EEG) biofeedback treatment regimen on perceptions of chemotherapy-induced neuropathic pain.

Secondary Objectives
2. Examine the effects of a neurofeedback training program on other aspects of quality of life (QOL) including cancer-related symptoms, general quality of life, sleep disturbances, and fatigue.
3. Identify cortical and subcortical brain regions from the quantitative EEG that could be associated with chronic chemotherapy-induced peripheral neuropathy and examine the association between changes in EEG patterns and changes in neuropathic pain perception and the extent to which these changes mediate the effects of the intervention.
4. Examine the processes underlying the efficacy of the intervention. A biopsychosocial model drawn from existing research on pain will be evaluated to identify factors that may mediate/moderate the effects of the intervention and predict adjustment. We will evaluate coping strategies, attachment, cognitive/emotional processing, and mood.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/18/2011

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	72

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) Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.

2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

3) Pain score >/= 4 on a 0-10 numeric pain scale and/or grade 3 neuropathic symptoms according to the National Cancer Institute's 4 point grading scale.

4) Pain must be related to chemotherapy (in the opinion of the treating physician).

5) Patients must have had neuropathic pain for a minimum of 3 months.

6) No plans to change pain medication regimen during the course of the study.

7) Off active chemotherapy treatment for minimum of 3 months.

8) Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.) therapies allowed as long as they will be continued during the course of the study.

9) Willing to come to MD Anderson for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of MDA main campus; or can participate in the therapy sessions from one of MDA's Regional Care Centers.

Exclusion Criteria:

1) Patients who are taking any antipsychotic medications.

2) Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy.

3) Patients who have ever been diagnosed with bipolar disorder or schizophrenia.

Links

Registration Number: NCT01278225
Study Information on Clinical Trials Registry (clinicaltrials.gov)