Musculoskeletal HealthNCT05921617
A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy
An observational study of Musculoskeletal Health, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Musculoskeletal Health
- How many people
- 870 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2023to 27 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative patients with hormone receptor-positive breast cancer and treated with aromatase inhibitors in Shanghai Cancer Center, Fudan University, Shanghai, China.
Who may be able to join
- 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.
Who cannot join
- Breast cancer recurrence or distant metastasis;
- With other malignant tumors;
- With cognitive or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Nursing, Fudan University
Shanghai, Shanghai Municipality, 200032
Feng Jing, (+86) 18021003217, 21111170001@m.fudan.edu.cn
Yan Hu, (+86) 13651860058, huyan@fudan.edu.cn
About this study
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
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Routine care
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hand function
Measured with score for assessment and quantification of chronic rheumatic affections of the hands (SACRAH).
Measured: 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).
Measured: 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).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Secondary outcomes (4)
Grip strength
Measured with CAMRY EH101 electronic grip strength meter (Made in China).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Bone mineral density
Measured with Lunar iDXA (Made in China).
Measured: Baseline, 12 months, and 24 months.
Depression and Anxiety
Measured with the Patient Health Questionnaire for Depression and Anxiety (PHQ-4).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Medication adherence
Measured with self-reported medication adherence visual analogue scale (VAS).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start27 Apr 2023
- Primary completion27 Apr 2025 (estimated)
- Study completion27 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal HealthStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Jing, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921617
- Sponsor's protocol ID
- FJing
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Musculoskeletal Health in Patients With Breast Cancer During Aromatase Inhibitors Therapy
- ClinicalTrials.gov ID
- NCT05921617
- Acronym / sponsor ID
- FJing
- Conditions
- Musculoskeletal Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 27 Apr 2025 (estimated)
- Study completion
- 27 Apr 2025 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative patients with hormone receptor-positive breast cancer and treated with aromatase inhibitors in Shanghai Cancer Center, Fudan University, Shanghai, China.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Breast cancer recurrence or distant metastasis;
- With other malignant tumors;
- With cognitive or psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionRoutine care | Other | Observation group |
Primary outcome
Changes in hand function
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Measured with score for assessment and quantification of chronic rheumatic affections of the hands (SACRAH).
Changes in wrist function
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Measured with Boston Carpal Tunnel Questionnaire (BCTQ).
Changes in knee or hip joint function
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Measured with Western Ontario and McMaster Osteoarthritis Index (WOMAC).
4 secondary outcomes
Grip strength
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Bone mineral density
Time frame: Baseline, 12 months, and 24 months.
Depression and Anxiety
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Medication adherence
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Health, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hand function (time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.