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Trial Title:
A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy
NCT ID:
NCT05921617
Condition:
Musculoskeletal Health
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
Routine care
Arm group label:
Observation group
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.
Criteria for eligibility:
Study pop:
Postoperative patients with hormone receptor-positive breast cancer and treated with
aromatase inhibitors in Shanghai Cancer Center, Fudan University, Shanghai, China.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Gender based:
Yes
Gender description:
Participant eligibility is based on self-representation of gender identity.
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
School of Nursing, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Jing
Phone:
(+86) 18021003217
Email:
21111170001@m.fudan.edu.cn
Contact backup:
Last name:
Yan Hu
Phone:
(+86) 13651860058
Email:
huyan@fudan.edu.cn
Start date:
April 27, 2023
Completion date:
April 27, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05921617
