Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/22/2015 |
| Start Date: | March 2012 |
| End Date: | September 2015 |
| Contact: | Norah L Henry, MD, PhD |
| Email: | norahh@med.umich.edu |
| Phone: | 734-936-4991 |
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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