Summary

Eligibility
for people ages up to 70 years (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Roland Krug

Description

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. We use Magnetic Resonance Imaging (MRI) as well as High-resolution peripheral quantitative computed tomography 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.

Details

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 and then undergo high-resolution peripheral quantitative computed tomography (HR-pQCT) of about 60 minutes. After completion of study, a subset of patients are followed up at 6 months.

Keywords

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 Breast Neoplasms High Resolution Peripheral Quantitative Computed Tomography Magnetic Resonance Imaging

Eligibility

You can join if…

Open to people ages up to 70 years

  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)
  • 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)

You CAN'T join if...

  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 WOMAC score >7 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

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04876378
Study Type
Observational
Last Updated