A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy

Fudan University

Status: Enrolling

Conditions: Musculoskeletal Health

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05921617

FJing

Details and patient eligibility

About

Postmenopausal women with hormone receptor-positive breast cancer are now prescribed aromatase inhibitors with 5 years or longer durations of therapy as recommended by clinical guidelines, which contributes to reducing breast cancer recurrence. However, aromatase inhibitors treatment is associated with a high incidence of musculoskeletal symptoms (MSS), often described as symmetrical pain, soreness in the joints, musculoskeletal pain, and joint stiffness, which even leads to bone loss, osteoporosis, and fractures. MSS reduces patients' quality of life and compliance with aromatase inhibitors therapy in up to one-half of women undergoing adjuvant aromatase inhibitors therapy, potentially compromising breast cancer outcomes. Therefore, this study aimed to monitor the musculoskeletal health of breast cancer patients during endocrine therapy to provide references for clinical practice.

Enrollment: 870 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Postoperative early breast cancer；
2. Hormone receptor-positive breast cancer diagnosed by pathology；
3. Aromatase inhibitor therapy (e.g., anastrozole, letrozole, exemestane) was initiated within 3 months;
4. Postmenopausal women, or premenopausal or perimenopausal women taking ovarian function inhibitors;
5. Informed consent and voluntary participation in the study.

Exclusion criteria

1. Breast cancer recurrence or distant metastasis;
2. With other malignant tumors;
3. With cognitive or psychiatric disorders.

Trial design

870 participants in 1 patient group

Observation group

Treatment:

Other: No intervention