Clinical trial · Observational
A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Musculoskeletal Health | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observation group
- interventionNames
- Other: No intervention
Primary outcomes (3)
- measure
- Changes in hand function
- timeFrame
- Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
- description
- Measured with score for assessment and quantification of chronic rheumatic affections of the hands (SACRAH).
- measure
- Changes in wrist function
- timeFrame
- Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
- description
- Measured with Boston Carpal Tunnel Questionnaire (BCTQ).
- measure
- Changes in knee or hip joint function
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available