Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
Verified December 2014 by University of Michigan
Information provided by (Responsible Party):
N. Lynn Henry, University of Michigan
First received: June 27, 2014
Last updated: December 1, 2014
Last verified: December 2014
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
||Observational Model: Case Control
Time Perspective: Prospective
||Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
Primary Outcome Measures:
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Women ages 18-75, inclusive, who have been diagnosed with early stage (i.e. 0-III) breast cancer with either moderate-severe chronic pain or no pain.
- Female gender
- Right-hand dominance
- Histologically proven stage 0-III carcinoma of the breast status post surgical resection.
- Radiation therapy and chemotherapy have been administered as indicated. Concurrent aromatase inhibitor, tamoxifen, trastuzumab, and/or bisphosphonate therapy are permitted.
- Presence of pain that developed or worsened since breast cancer diagnosis not specifically due to an identifiable trauma (e.g. fracture or injury) and has been present for at least 3 months.
- Average pain must be at least 4 on a 0-10 scale over the past 7 days.
- Performance status 0-2
- Age between 18 and 75 years old, inclusive
- The patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
- Presence of significant medical illness: autoimmune/inflammatory diseases, cardiopulmonary disorders (i.e. angina, congestive heart failure, severe COPD), uncontrolled endocrine disorders (i.e. hypothyroidism, diabetes), vestibular neuritis, Meniere's syndrome, benign paroxysmal positional vertigo, or known/previously diagnosed structural disorder of the peripheral vestibular system.
- Routine daily use of duloxetine and/or milnacipran
- Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, or substance abuse within 2 years)
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
- Thumbnail abnormalities on either hand (such as due to chemotherapy or trauma, or artificial nails) that are likely to alter pain perception during testing
- Contraindications to fMRI, including severe claustrophobia, presence of tissue expanders for breast reconstruction, and presence of a port-a-cath that is incompatible with MRI
- Pregnant or nursing
- The Principal Investigator determines that the patient is acting in ways that would lessen her chances of completing the study
- Prior diagnosis of fibromyalgia
- BMI > 40
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: NCT02180594
|University of Michigan
|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 |
University of Michigan
||Norah L Henry, MD, PhD
||University of Michigan
No publications provided
||N. Lynn Henry, Assistant Professor, Internal Medicine, University of Michigan
History of Changes
|Other Study ID Numbers:
||HUM00055687, UMCC 2011.115
|Study First Received:
||June 27, 2014
||December 1, 2014
||United States: IRBMED University of Michigan
Keywords provided by University of Michigan:
early stage breast cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 31, 2015
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