Clinical trial NCT04876378: Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand
Official title: Impact of Breast Cancer Treatment on Joint Health, Cartilage Composition, and Bone Structure in the Knee and Hand
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage IB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Hormone Receptor Positive Breast Adenocarcinoma
Prognostic Stage I Breast Cancer AJCC v8
Prognostic Stage IA Breast Cancer AJCC v8
Prognostic Stage IB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 8
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of breast cancer and normal controls.

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 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
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:

1. 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
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

Primary outcomes:
measure: Mean differences in hyaline cartilage biochemical composition
timeFrame: Up to 6 months
measure: Differences in morphological joint abnormalities
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Roland Krug, PhD
role: PRINCIPAL_INVESTIGATOR
References: