Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
Verified December 2014 by University of Michigan Cancer Center
Information provided by (Responsible Party):
Lynn Henry, University of Michigan Cancer Center
First received: July 9, 2012
Last updated: December 21, 2014
Last verified: December 2014
The purpose of this study is to better understand why some women with breast cancer develop chronic pain.
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Breast Cancer Survivors with and without Chronic Pain
- Breast Cancer Survivor with and without chronic pain
- Able to undergo MRI
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
|University of Michigan Comprehensive Cancer Center
|Ann Arbor, Michigan, United States, 48109 |
|Contact: Norah L Henry, MD 734-936-4991 email@example.com |
|Contact: Cancer AnswerLine 1-800-865-1125 firstname.lastname@example.org |
||Lynn Henry, MD
||University of Michigan Cancer Center
No publications provided
ClinicalTrials.gov processed this record on March 03, 2015
||Lynn Henry, Principal Investigator, University of Michigan Cancer Center
History of Changes
|Other Study ID Numbers:
||UMCC 2011.115, HUM 55687
|Study First Received:
||July 9, 2012
||December 21, 2014
||United States: Institutional Review Board