Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
N. Lynn Henry, University of Michigan
ClinicalTrials.gov Identifier:
NCT02180594
First received: June 27, 2014
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition
Chronic Pain
Early Stage Breast Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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


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: 40
Study Start Date: March 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
No Pain
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
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

Contacts
Contact: Norah L Henry, MD, PhD 734-936-4991 norahh@med.umich.edu

Locations
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         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Norah L Henry, MD, PhD University of Michigan
  More Information

No publications provided

Responsible Party: N. Lynn Henry, Assistant Professor, Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT02180594     History of Changes
Other Study ID Numbers: HUM00055687, UMCC 2011.115
Study First Received: June 27, 2014
Last Updated: June 30, 2014
Health Authority: United States: IRBMED University of Michigan

Keywords provided by University of Michigan:
chronic pain
early stage breast cancer
fMRI

Additional relevant MeSH terms:
Breast Neoplasms
Chronic Pain
Mastodynia
Breast Diseases
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014