Tailored Exercise to Reduce Aromatase Inhibitor Associated Musculoskeletal Symptoms (TAILOR-Ex)

February 26, 2026 updated by: suthinee ithimakin, Mahidol University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suthinee Ithimakin, M.D
        • Sub-Investigator:
          • Suchaya Tanissa, M.D
        • Sub-Investigator:
          • Concord Wongkraisri, M.D
        • Sub-Investigator:
          • Pisit Lertwanich, M.D
        • Sub-Investigator:
          • Suebwong Chutapisit, M.D
        • Sub-Investigator:
          • Akarin Nimmannit, M.D
        • Sub-Investigator:
          • Kanchana Inthiraj

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • breast cancer patients with starting adjuvant aromatase inhibitor within 4 weeks
  • able to read and write

Exclusion Criteria:

  • chronic arthritis
  • history of heart failure or acute coronary syndrome within 6 months
  • individuals who exercises regularly more than 150 minutes/week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
routine practice
Active Comparator: tailored exercise
tailored exercise advise from sport scientist
Behavioral: tailored exercise
tailored suitable exercise to individuals recommended for the aim of aerobic exercise at 150 minutes per week and strengthening exercise twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aromatase inhibitor associated musculoskeletal symptoms (AIMSS)
Time Frame: 12 months
occurrence of AIMSS
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
worsening pain
Time Frame: 12 months
reduce numerical scale of pain more than 2 points
12 months
body weight
Time Frame: 12 months
body weight change
12 months
quality of life FACT-ES
Time Frame: 12 months
FACT-ES score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2026

Primary Completion (Estimated)

February 18, 2029

Study Completion (Estimated)

August 18, 2029

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1171/2568(IRB3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase Inhibitor

Clinical Trials on tailored exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe