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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01639417
First received: July 9, 2012
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to better understand why some women with breast cancer develop chronic pain.

Condition
Pain
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Determination of differences in pain sensitivity and functional MRI in different groups of patients. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: May 2012
Study Completion Date: November 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

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 
Study First Received: July 9, 2012
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 09, 2016