Breast Cancer Clinical Trial

Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand

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 breast cancer and healthy patients. The investigators will use Magnetic Resonance Imaging (MRI) to assess the quality of hand and knee joints. This study may help doctors learn more about hand and knee joint pain that occurs during aromatase inhibitor treatment.

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Full 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.

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.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

8

Study ID:

NCT04876378

Recruitment Status:

Terminated

Sponsor:

University of California, San Francisco

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There is 1 Location for this study

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University of California San Francisco
San Francisco California, 94143, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

8

Study ID:

NCT04876378

Recruitment Status:

Terminated

Sponsor:


University of California, San Francisco

How clear is this clinincal trial information?

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