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

Study Overview
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Brief Summary
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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.

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

Conditions
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Musculoskeletal Health

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postoperative early breast cancer； Hormone receptor-positive breast cancer diagnosed by pathology； Aromatase inhibitor therapy (e.g., anastrozole, letrozole, exemestane) was initiated within 3 months; Postmenopausal women, or premenopausal or perimenopausal women taking ovarian function inhibitors; Informed consent and voluntary participation in the study. Exclusion Criteria: Breast cancer recurrence or distant metastasis; With other malignant tumors; With cognitive or psychiatric disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation group<br> | Other: No intervention<br>* Routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hand function | Measured with score for assessment and quantification of chronic rheumatic affections of the hands (SACRAH). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | 
| Changes in wrist function | Measured with Boston Carpal Tunnel Questionnaire (BCTQ). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | 
| Changes in knee or hip joint function | Measured with Western Ontario and McMaster Osteoarthritis Index (WOMAC). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Measured with CAMRY EH101 electronic grip strength meter (Made in China). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | 
| Bone mineral density | Measured with Lunar iDXA (Made in China). | Baseline, 12 months, and 24 months. | 
| Depression and Anxiety | Measured with the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. | 
| Medication adherence | Measured with self-reported medication adherence visual analogue scale (VAS). | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months. |