We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01639417
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Cancer Center

Brief Summary:
The purpose of this study is to better understand why some women with breast cancer develop chronic pain.

Condition or disease
Pain Breast Cancer

Detailed Description:
Women with breast cancer who either have chronic pain or who do not have chronic pain will be asked to enroll. Those who participate will have pictures taken of their brain using MRI when they are lying still and also when pressure is being applied to their thumbnails. These pictures will be compared to patients without breast cancer who do not have pain and to those who have other types of pain, such as fibromyalgia. By taking and analyzing these pictures the investigators hope to understand more about why breast cancer survivors develop pain after their diagnosis and treatment. In the future the investigators hope to better treat the pain or possibly even prevent the pain from occurring in the first place.

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
Study Start Date : May 2012
Primary Completion Date : July 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Determination of differences in pain sensitivity and functional MRI in different groups of patients. [ Time Frame: 6 months ]
    The primary objective of this pilot trial is to determine if there may be differences in mechanical pain sensitivity and functional MRI brain activation patterns in breast cancer survivors with chronic pain as compared to breast cancer patients without chronic pain, to patients with fibromyalgia, or to healthy controls.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast Cancer Survivors with and without Chronic Pain
Criteria

Inclusion Criteria:

  • Breast Cancer Survivor with and without chronic pain
  • Able to undergo MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639417


Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Lynn Henry
Investigators
Principal Investigator: Lynn Henry, MD University of Michigan Cancer Center

Responsible Party: Lynn Henry, Principal Investigator, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01639417     History of Changes
Obsolete Identifiers: NCT02180594
Other Study ID Numbers: UMCC 2011.115
HUM 55687 ( Other Identifier: HUM 55687 )
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Breast Neoplasms
Chronic Pain
Mastodynia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms