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

NCT ID: NCT05921617

Last Updated: 2023-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

870 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-27

Study Completion Date

2025-04-27

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.

Detailed Description

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Conditions

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Musculoskeletal Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation group

No intervention

Intervention Type OTHER

Routine care

Interventions

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No intervention

Routine care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Feng Jing

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Nursing, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Feng Jing

Role: primary

(+86) 18021003217

Yan Hu

Role: backup

(+86) 13651860058

Other Identifiers

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FJing

Identifier Type: -

Identifier Source: org_study_id

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