Neuropathic Pain in Survivors of Breast Cancer - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Pfizer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00535067

Purpose

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:

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

Condition	Intervention
Breast Cancer	Behavioral: Questionnaire

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Neuropathic Pain in Survivors of Breast Cancer

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

Primary Outcome Measures:

To learn about pain among individuals who have been treated for breast cancer with paclitaxel. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

This study will look at how much pain you have, the factors related to the pain, and how the pain affects your life. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	635
Study Start Date:	September 2007
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients that are survivors of Breast Cancer.	Behavioral: Questionnaire Questionnaires taking 60 minutes total to complete.

Detailed Description:

You have already been contacted by phone about participating in this study. You have received study documents (this consent and the study questionnaires) because you said over the phone that you would like to participate in this study.

In this study you will be asked to complete questionnaires that will ask about any pain you may be experiencing and about the quality of your life.

These questionnaires will also ask for demographic information (such as age, race, and sex) and about your health. It should take about 1 hour to complete all of the questionnaires. In addition to the questionnaires, you will also be asked questions about any medications you may currently be taking for pain. All of the information you include on the questionnaires will be kept confidential. There are no right or wrong answers to the questions. A postage-paid return envelope has been provided for you to return this consent and the questionnaires.

Researchers are interested in how pain is related to certain treatments and medical conditions. As part of this study, researchers will review your medical records to see what type of cancer treatment you received and whether you had any pain related to the treatment. They will also see if you had any non-cancer health conditions that may have affected pain and quality of life.

This survey is for research purposes only. Your healthcare provider will not be informed of your responses to this survey. If you are experiencing severe pain and/or other symptoms, please contact your healthcare provider. The study staff has also included a list of community resources that you may contact for different types of services.

Your participation in this study will be over once you mail back the consent and questionnaires.

This is an investigational study. Up to 635 individuals will be asked to take part in this study. All will be enrolled at M. D. 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

Breast Cancer survivors.

Criteria

Inclusion Criteria:

Breast cancer patients who were participants in clinical trials (ID98-240; ID94-002) for taxanes during 1994-2001
Alive and with current contact information
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:

1) None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535067

Contacts

Contact: Cielito C. Reyes-Gibby, DrPH

713-792-1816

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Cielito C. Reyes-Gibby, DrPH

Sponsors and Collaborators

M.D. Anderson Cancer Center

Pfizer

Investigators

Principal Investigator:

Cielito C. Reyes-Gibby, DrPH

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Cielito C. Reyes-Gibby, DrPH/Assistant Professor )
Study ID Numbers:	2006-0761
Study First Received:	September 21, 2007
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00535067 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer
Questionnaire
Survey
Neuropathic Pain

Cancer Survivors
Quality of Life
QOL

Study placed in the following topic categories:

Skin Diseases
Quality of Life
Breast Neoplasms
Pain
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009