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

NCT04876378 | Terminated

• 2 other identifiers: 20923NCI-2020-03535
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Mean differences in hyaline cartilage biochemical composition

  Will determine differences in hyaline cartilage biochemical composition (using magnetic resonance imaging) between breast cancer patients under aromatase inhibitor (AI) treatment. Linear regression models will be used to assess differences in joint parameters outcomes between healthy controls, AI patients with pain, and AI patients without pain (predictors).

  Up to 6 months

• Differences in morphological joint abnormalities

  Will determine differences in morphological joint abnormalities (using semi-quantitative magnetic resonance-based scores) between breast cancer patients under aromatase inhibitor (AI) treatment. Linear regression models will be used to assess differences in joint parameters outcomes between healthy controls, AI patients with pain, and AI patients without pain (predictors).

  Up to 6 months

Study Arms (1)

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.

Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Interventions

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (questionnaires, MRI)

Questionnaire Administration OTHER

Complete questionnaires

Diagnostic (questionnaires, MRI)

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of breast cancer and normal controls.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Roland Krug, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 6, 2021
• Study Start: May 18, 2020
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)