Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase InhibitorTAILOR-ExNCT07448558
Tailored Exercise to Reduce Aromatase Inhibitor Associated Musculoskeletal Symptoms
A study testing tailored exercise in people with Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase Inhibitor, run by Mahidol University at 1 site in Thailand.
Trial summary
A randomized controlled study evaluating effect of tailored exercise compared to routine practice as a preventive measure of aromatase inhibitor associated musculoskeletal related symptoms in early breast cancer patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase Inhibitor
- What is being tested?
- tailored exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteThailand
- Study dates
- 18 Feb 2026to 18 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients with starting adjuvant aromatase inhibitor within 4 weeks
- able to read and write
Who cannot join
- chronic arthritis
- history of heart failure or acute coronary syndrome within 6 months
- individuals who exercises regularly more than 150 minutes/week
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
Suthinee Ithimakin, 0898127440, aesi105@yahoo.co.th
aesi105@yahoo.co.th
About this study
Official title: Effectiveness of Tailored Home-based Exercise on Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitor: A Randomized, Controlled Trial
A randomized controlled study evaluating effect of tailored exercise compared to routine practice as a preventive measure of aromatase inhibitor associated musculoskeletal related symptoms in early breast cancer patients
- Being tested
- tailored exercise
- Keywords
- exercise, aromatase inhibitor, musculoskeletal associated symptoms, ิbreast cancer
- Medical subject headings
- Motor Activity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored exerciseBehavioural
tailored suitable exercise to individuals recommended for the aim of aerobic exercise at 150 minutes per week and strengthening exercise twice a week
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | routine practice |
| tailored exercise | Active comparator | tailored exercise advise from sport scientist Receives: Behavioral: tailored exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aromatase inhibitor associated musculoskeletal symptoms (AIMSS)
occurrence of AIMSS
Measured: 12 months
Secondary outcomes (3)
worsening pain
reduce numerical scale of pain more than 2 points
Measured: 12 months
body weight
body weight change
Measured: 12 months
quality of life FACT-ES
FACT-ES score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start18 Feb 2026
- Primary completion18 Feb 2029 (estimated)
- Study completion18 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase InhibitorStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suthinee ithimakin, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448558
- Sponsor's protocol ID
- 1171/2568(IRB3)
- Acronym
- TAILOR-Ex
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu G, Zheng J, Zhang L. The effect of exercise on aromatase inhibitor-induced musculoskeletal symptoms in breast cancer survivors :a systematic review and meta-analysis. Support Care Cancer. 2020 Apr;28(4):1587-1596. doi: 10.1007/s00520-019-05186-1. Epub 2019 Dec 18.
PubMed 31853701Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.
PubMed 35005781Henry NL, Giles JT, Ang D, Mohan M, Dadabhoy D, Robarge J, Hayden J, Lemler S, Shahverdi K, Powers P, Li L, Flockhart D, Stearns V, Hayes DF, Storniolo AM, Clauw DJ. Prospective characterization of musculoskeletal symptoms in early stage breast cancer patients treated with aromatase inhibitors. Breast Cancer Res Treat. 2008 Sep;111(2):365-72. doi: 10.1007/s10549-007-9774-6. Epub 2007 Oct 6.
PubMed 17922185
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tailored Home-based Exercise on Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitor: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07448558
- Acronym / sponsor ID
- TAILOR-Ex / 1171/2568(IRB3)
- Keywords
- exercise, aromatase inhibitor, musculoskeletal associated symptoms, ิbreast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 18 Feb 2029 (estimated)
- Study completion
- 18 Aug 2029 (estimated)
- First posted
- 4 Mar 2026 (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.
A randomized controlled study evaluating effect of tailored exercise compared to routine practice as a preventive measure of aromatase inhibitor associated musculoskeletal related symptoms in early breast cancer patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –routine practice |
| tailored exercise | Active comparator | Behavioral: tailored exercisetailored exercise advise from sport scientist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- breast cancer patients with starting adjuvant aromatase inhibitor within 4 weeks
- able to read and write
Key exclusion criteria (3 listed)
- chronic arthritis
- history of heart failure or acute coronary syndrome within 6 months
- individuals who exercises regularly more than 150 minutes/week
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 |
|---|---|---|
| tailored exercisetailored suitable exercise to individuals recommended for the aim of aerobic exercise at 150 minutes per week and strengthening exercise twice a week | Behavioural | tailored exercise |
Primary outcome
Aromatase inhibitor associated musculoskeletal symptoms (AIMSS)
Time frame: 12 months
occurrence of AIMSS
3 secondary outcomes
worsening pain
Time frame: 12 months
body weight
Time frame: 12 months
quality of life FACT-ES
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 31853701Lu G, Zheng J, Zhang L. The effect of exercise on aromatase inhibitor-induced musculoskeletal symptoms in breast cancer survivors :a systematic review and meta-analysis. Support Care Cancer. 2020 Apr;28(4):1587-1596. doi: 10.1007/s00520-019-05186-1. Epub 2019 Dec 18.
- Background: PubMed 35005781Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.
- Background: PubMed 17922185Henry NL, Giles JT, Ang D, Mohan M, Dadabhoy D, Robarge J, Hayden J, Lemler S, Shahverdi K, Powers P, Li L, Flockhart D, Stearns V, Hayes DF, Storniolo AM, Clauw DJ. Prospective characterization of musculoskeletal symptoms in early stage breast cancer patients treated with aromatase inhibitors. Breast Cancer Res Treat. 2008 Sep;111(2):365-72. doi: 10.1007/s10549-007-9774-6. Epub 2007 Oct 6.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tailored exercise in people with Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase Inhibitor, run by Mahidol University at 1 site in Thailand.
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 2 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suthinee Ithimakin, M.D (+66898127440, aesi105@yahoo.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aromatase inhibitor associated musculoskeletal symptoms (AIMSS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07448558, which also lists 3 linked publications.
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 4 Mar 2026.