Breast CancerNCT05628077
Prevalence and Risk Factors for Pain and Related Adverse Reactions Among Breast Cancer Survivors on Aromatase Inhibitors
An observational study of Breast Cancer and Aromatase Inhibitors, run by Peking University People's Hospital at 1 site in China.
Trial summary
We obtained the occurrence of pain sensation, pain mood, sleep, etc. during endocrine therapy in breast cancer patients through telephone follow-up, and analyzed risk factors through artificial intelligence Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer, Aromatase Inhibitors, Endocrine Therapy
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2022to 20 Apr 2023
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: I-III Breast cancer survivors on aromatase inhibitors
Who may be able to join
- Breast cancer survivors on aromatase inhibitors
Who cannot join
- Advanced breast cancer
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People'S Hospital
Beijing, 000000
Huifang Li, 18538078485, lihuifang19910318@outlook.com
About this study
Official title: Doctor of Medical Sciences
We obtained the occurrence of pain sensation, pain mood, sleep, etc. during endocrine therapy in breast cancer patients through telephone follow-up, and analyzed risk factors through artificial intelligence
- Conditions
- Breast Cancer, Aromatase Inhibitors, Endocrine Therapy, Pain, Anxiety, Depression
- Being tested
- No intervention
- Medical subject headings
- Breast Neoplasms, Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| PAIN | Not described Receives: Other: No intervention | |
| NO PAIN | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and risk factors for pain and related adverse reactions among breast cancer survivors on aromatase inhibitors
Measured: 2022-10 ---2023-03
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start30 Dec 2022
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628077
- Sponsor's protocol ID
- yifeng
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doctor of Medical Sciences
- ClinicalTrials.gov ID
- NCT05628077
- Acronym / sponsor ID
- yifeng
- Conditions
- Breast Cancer, Aromatase Inhibitors, Endocrine Therapy, Pain, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 28 Nov 2022 (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.
We obtained the occurrence of pain sensation, pain mood, sleep, etc. during endocrine therapy in breast cancer patients through telephone follow-up, and analyzed risk factors through artificial intelligence
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAIN | – | Other: No intervention |
| NO PAIN | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- I-III Breast cancer survivors on aromatase inhibitors
Key inclusion criteria (1 listed)
- Breast cancer survivors on aromatase inhibitors
Key exclusion criteria (1 listed)
- Advanced breast cancer
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 interventionNo intervention | Other | NO PAIN, PAIN |
Primary outcome
Prevalence and risk factors for pain and related adverse reactions among breast cancer survivors on aromatase inhibitors
Time frame: 2022-10 ---2023-03
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 Breast Cancer and Aromatase Inhibitors, run by Peking University People's Hospital 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 1 inclusion and 1 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 7 Mar 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?
Prevalence and risk factors for pain and related adverse reactions among breast cancer survivors on aromatase inhibitors (time frame: 2022-10 ---2023-03). 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 7 Mar 2023.