MDACC Study Summary 2006-0761

Study Summary
No. 2006-0761:.......Breast......Cielito C. Reyes-Gibby......Epidemiology

Study Summary Title



Study Summary Number:	2006-0761

Study Title:	Neuropathic pain in survivors of breast cancer

Physician

New Patient Referral



Name:	Cielito C. Reyes-Gibby	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-1816 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Not applicable

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable


Description/ Intervention:	The goal of this research study is to learn about pain among individuals who have been treated for breast cancer with paclitaxel. This study will look at how much pain you have, the factors related to the pain, and how the pain affects your life.

Study Objectives / Outcomes

The objectives of this study are to: 1) describe the prevalence of neuropathic pain (NP) in breast cancer survivors and 2) to develop preliminary statistical risk models for predicting the risk for NP incorporating disease-related variables (e.g., stage of disease, location of tumor), treatment variables (chemotherapy, dose, duration; and other cancer therapy), clinical health status (e.g., comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race).

We will also gather data to answer the following secondary aims:

1. To assess the impact of NP on quality of life.
2. To assess the current management of NP in cancer (current medication, duration of such treatment, reasons for discontinuation) and the outcomes of this management.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	03/02/2007

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	N/A

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) Breast cancer patients who were participants in clinical trials (ID98-240; ID94-002) for taxanes during 1994-2001

2) Alive and with current contact information

3) Age >/= 18 years. (This restriction is based on inclusion criteria for the clinical trials from which subjects will be recruited. All patients will be at least 18 years or older for this study.)

Exclusion Criteria:

1) None

Links

Registration Number: NCT00535067
Study Information on Clinical Trials Registry (clinicaltrials.gov)