Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02180594 : Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients
PhaseN/A
AgesMin: 18 Years Max: 75 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02180594      |      Link to official Clinicaltrials.gov listing
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