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

NCT05921617 | Unknown

• 1 other identifier: FJing
• Study Type: observational
• Target: 870
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Health

Outcome Measures

Primary Outcomes (3)

• Changes in hand function

  Measured with score for assessment and quantification of chronic rheumatic affections of the hands (SACRAH).

  Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

• Changes in wrist function

  Measured with Boston Carpal Tunnel Questionnaire (BCTQ).

  Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

• Changes in knee or hip joint function

  Measured with Western Ontario and McMaster Osteoarthritis Index (WOMAC).

  Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

Secondary Outcomes (4)

• Grip strength

  Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

• Bone mineral density

  Baseline, 12 months, and 24 months.

• Depression and Anxiety

  Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

• Medication adherence

  Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

Study Arms (1)

Observation group

Other: No intervention

Interventions

No intervention OTHER

Routine care

Observation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Postoperative early breast cancer；
• Hormone receptor-positive breast cancer diagnosed by pathology；
• Aromatase inhibitor therapy (e.g., anastrozole, letrozole, exemestane) was initiated within 3 months;
• Postmenopausal women, or premenopausal or perimenopausal women taking ovarian function inhibitors;
• Informed consent and voluntary participation in the study.

You may not qualify if:

• Breast cancer recurrence or distant metastasis;
• With other malignant tumors;
• With cognitive or psychiatric disorders.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

School of Nursing, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 27, 2023
• Study Start: April 27, 2023
• Primary Completion: April 27, 2025
• Study Completion: April 27, 2025
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)