Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
The investigators are trying to learn more about why some patients with breast cancer develop chronic pain after diagnosis and treatment. A participant will fill out questionnaires about her pain symptoms and undergo pain-pressure testing, a test that measures how sensitive she is to pain by applying pressure to the thumbnail. Then, the participant will repeat the pain sensitivity testing while pictures are taken of her brain using an functional magnetic resonance imaging scanner. The functional magnetic resonance imaging does not require contrast imaging (i.e. dye injection) and there is no risk of radiation. The investigators hypothesize that women with chronic pain in the breast cancer survivor population will respond to painful stimuli differently compared to those without chronic pain.
Early Stage Breast Cancer
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients|
- Feasibility of study procedures [ Time Frame: During QST evaluation ] [ Designated as safety issue: No ]We are assessing whether patients are willing and able to undergo assessment with fMRI
- Brain activation patterns [ Time Frame: during fMRI scan ] [ Designated as safety issue: No ]Will assess differences in brain activation patterns between cases and controls both before painful stimulation and during painful stimulation.
- Neurotransmitter concentrations in relevant brain regions [ Time Frame: during fMRI evaluation ] [ Designated as safety issue: No ]Concentrations of glutamine and glutamate before and during painful stimulation will be compared between cases and controls.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Chronic pain cohort
Participants in the "pain," or case, group are patients with early stage breast cancer with chronic pain rated at least average 4 out of 10 that has developed or worsened since breast cancer diagnosis.
Participants in the "no pain," or control, group are patients with early stage breast cancer who do not experience chronic pain. They are being matched to cases based on age, prior breast cancer treatments, and current use of antidepressant medications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02180594
|Contact: Norah L Henry, MD, PhDfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Norah L Henry, MD, PhD 800-865-1125 CancerAnswerLine@med.umich.edu|
|Principal Investigator: Norah L Henry, MD, PhD|
|Principal Investigator:||Norah L Henry, MD, PhD||University of Michigan|