Clinical trial NCT05921617: A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy
Official title: A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Health
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 870
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postoperative patients with hormone receptor-positive breast cancer and treated with aromatase inhibitors in Shanghai Cancer Center, Fudan University, Shanghai, China.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in hand function
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
measure: Changes in wrist function
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
measure: Changes in knee or hip joint function
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Secondary outcomes:
measure: Grip strength
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
measure: Bone mineral density
timeFrame: Baseline, 12 months, and 24 months.
measure: Depression and Anxiety
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
measure: Medication adherence
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: School of Nursing, Fudan University
state: Shanghai
Study officials:
References: