Status:
TERMINATED
Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand
Lead Sponsor:
University of California, San Francisco
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Eligibility:
All Genders
Up to 70 years
Brief Summary
This study investigates the impact of breast cancer treatment on joint health, cartilage, composition, and bone structure in the knee and hand in patients with hormone-receptor positive stage I-III br...
Detailed Description
PRIMARY OBJECTIVE: 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. OU...
Eligibility Criteria
Inclusion
- Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
- 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)
- Age \<= 70 years old
- 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
- History of prior traumatic injury at knee joint or severe degenerative joint disease or osteoarthritis defined as having a history of prior joint replacement or moderate to severe knee pain prior to initiation of AI
- History of claustrophobia
- 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
Key Trial Info
Start Date :
May 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 24 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04876378
Start Date
May 18 2020
End Date
May 24 2022
Last Update
September 9 2022
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143