Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand
NCT ID: NCT04876378
Last Updated: 2022-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
8 participants
OBSERVATIONAL
2020-05-18
2022-05-24
Brief Summary
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Detailed Description
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I. To investigate pathological alterations in cartilage and joints in breast cancer patients on aromatase inhibitor (AI)s with and without pain and in healthy control patients.
OUTLINE:
Patients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI of about 60 minutes.
After completion of study, a subset of patients are followed up at 6 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diagnostic (questionnaires, MRI)
Patients complete a series of questionnaires over 15 minutes about knee function and pain, as well as physical activity. Patients also undergo an MRI over 60 minutes.
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Complete questionnaires
Interventions
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Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Breast cancer patients with either natural or chemically induced menopause with stage 1-3 hormone receptor-positive breast cancers and on AI for at least one year OR healthy postmenopausal women
Breast cancer patients on aromatase inhibitors (AI) may fall into one of the three following groups:
* Patients with knee pain with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) \>= 5, but no or minimal hand/wrist pain
* Patients with self-reported moderate or severe hand/wrist pain but no or only mild knee pain (WOMAC =\< 7)
* Patients with no or minimal hand/wrist or knee pain (WOMAC =\< 7)
3. Age \<= 70 years old
4. Ability to read and complete quality of life surveys in English (or have a family member or friend available to translate and assist in completing surveys)
Exclusion Criteria
2. History of claustrophobia
3. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data, including prior history of implanted devices with ferromagnetic objects
70 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Roland Krug, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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NCI-2020-03535
Identifier Type: REGISTRY
Identifier Source: secondary_id
20923
Identifier Type: -
Identifier Source: org_study_id
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