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Recruiting NCT07448558

Tailored Exercise to Reduce Aromatase Inhibitor Associated Musculoskeletal Symptoms

No phase Interventional Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase Inhibitor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tailored exercise.
Who it may be relevant to
Registry conditions: Patients With Early Breast Cancer Who Initiating Adjuvant Aromatase Inhibitor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

Interventions

  • 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

Primary outcome measures

  • Aromatase inhibitor associated musculoskeletal symptoms (AIMSS) [Time frame: 12 months]
Secondary outcome measures (3)
  • worsening pain [Time frame: 12 months]
  • body weight [Time frame: 12 months]
  • quality of life FACT-ES [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Thailand · 1 center
  • Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok

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. PMID 31853701
  • 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 35005781
  • 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 17922185

Identifiers

NCT: NCT07448558 · 1171/2568(IRB3)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗