NCT07448558

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Aug 2029

Study Start

First participant enrolled

February 18, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2029

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 26, 2026

Last Update Submit

February 26, 2026

Conditions

Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase Inhibitor

Keywords

exercisearomatase inhibitormusculoskeletal associated symptomsิbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Aromatase inhibitor associated musculoskeletal symptoms (AIMSS)

    occurrence of AIMSS

    12 months

Secondary Outcomes (3)

  • worsening pain

    12 months

  • body weight

    12 months

  • quality of life FACT-ES

    12 months

Study Arms (2)

control

NO INTERVENTION

routine practice

tailored exercise

ACTIVE COMPARATOR

tailored exercise advise from sport scientist

Behavioral: tailored exercise

Interventions

tailored exerciseBEHAVIORAL

tailored suitable exercise to individuals recommended for the aim of aerobic exercise at 150 minutes per week and strengthening exercise twice a week

tailored exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31853701BACKGROUND

  • Roberts 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.

    PMID: 35005781BACKGROUND

  • Henry 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.

    PMID: 17922185BACKGROUND

MeSH Terms

Conditions

Motor ActivityBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Suthinee Ithimakin, M.D

CONTACT

+66898127440aesi105@yahoo.co.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

February 18, 2029

Study Completion (Estimated)

August 18, 2029

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)