Musculoskeletal Health
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
Routine care
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hand function | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | Measured with score for assessment and quantification of chronic rheumatic affections of the hands (SACRAH). |
| Changes in wrist function | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | Measured with Boston Carpal Tunnel Questionnaire (BCTQ). |
| Changes in knee or hip joint function | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | Measured with Western Ontario and McMaster Osteoarthritis Index (WOMAC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | Measured with CAMRY EH101 electronic grip strength meter (Made in China). |
| Medication adherence | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | Measured with self-reported medication adherence visual analogue scale (VAS). |
| Bone mineral density | Baseline, 12 months, and 24 months. | Measured with Lunar iDXA (Made in China). |
| Depression and Anxiety | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | Measured with the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). |
Countries
China
Outcome results
None listed