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Prospective Pilot Study to Determine the Effect of Aromatase Inhibitor-induced Estrogen Depletion on Evoked Pain Threshold and Psychosocial Factors in Breast Cancer Patients


N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer, Pain, Arthralgia

Thank you

Trial Information

Prospective Pilot Study to Determine the Effect of Aromatase Inhibitor-induced Estrogen Depletion on Evoked Pain Threshold and Psychosocial Factors in Breast Cancer Patients


Inclusion Criteria:



- Female gender

- Postmenopausal, age 21 or greater

- Stage 0-III estrogen receptor and/or progesterone receptor positive breast cancer who
will be receiving a standard dose of letrozole, anastrozole, or exemestane

- Performance status 0-2

- Willing to sign the consent form

Exclusion Criteria:

- Average pain >=8/10 over the past 24 hours

- Peripheral sensory neuropathy grade 2 or higher

- Personal history of schizophrenia, or suicidal ideation or attempt within the past 2
years

- Thumbnail abnormalities on either hand that are likely to alter pain perception
during testing

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change in pain threshold between the baseline and 3 mo assessments

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Norah L Henry, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: University of Michigan Comprehensive Cancer Center Data Safety and Monitoring Board

Study ID:

HUM00026034

NCT ID:

NCT01814397

Start Date:

July 2009

Completion Date:

February 2013

Related Keywords:

  • Breast Cancer
  • Pain
  • Arthralgia
  • Aromatase inhibitor
  • Pain threshold
  • Arthralgia
  • Breast Neoplasms

Name

Location
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752