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

Recruiting

• Conditions: Musculoskeletal Health
• Interventions: Other: No intervention

• Registration Number: NCT05921617
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-27
• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Primary Completion: 2025-04-27
• Study Completion: 2025-04-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 870

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation group	No intervention	-

Primary Outcome Measures

Name	Time	Method
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).
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).

Secondary Outcome Measures

Name	Time	Method
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).
Bone mineral density	Baseline, 12 months, and 24 months.	Measured with Lunar iDXA (Made in China).
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).

Trial Locations

Locations (1)

School of Nursing, Fudan University; 🇨🇳 Shanghai, Shanghai, China