Yoga intervention for women with hormone-receptor positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of yoga on women diagnosed with hormone-receptor positive breast cancer who are experiencing musculoskeletal complaints due to endocrine therapy. Participants will engage in live yoga sessions, either in-person or remotely, to assess improvements in pain, stiffness, and overall quality of life. The study aims to provide a non-pharmacological approach to alleviate the side effects of cancer treatment, which often lead to early discontinuation of therapy. By focusing on this specific population, the study seeks to enhance treatment adherence and patient well-being.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be diagnosed with oestrogen-receptor positive stage I-III breast cancer,
* Use of aromatase inhibitors or Tamoxifen (\>4 months and will continue using it for at least six months),
* Have finished primary treatment (chemotherapy, radiotherapy, surgery) for at least 12 weeks,
* Experience musculoskeletal complaints (\>3 months, which are at least mild in severity (i.e., score of ≥ 3 for worst pain item of a modified version of the Brief Pain Inventory \[BPI\](16, 42))., which started or exacerbated after initiation of endocrine treatment,
* Be stabilized on menopausal symptom medication or antidepressants for at least three months and three weeks, respectively, if applicable, and
* Be able to read, speak and understand Dutch or English.

Exclusion Criteria:

* Too physically active (i.e., \>150 minutes/week of self-reported moderate-to-vigorous or leisure and sports activities)
* Following (during the last 6 months), or planned to follow yoga classes on a structural base
* Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication
* Participated in the intervention group of an exercise study during breast cancer treatment
* Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the study team
* More than 3 weeks not able to attend training sessions during the intervention period
* A body mass index (BMI) of \>35 kg/m2

Where it's running

• University Medical Center Utrecht (UMC Utrecht)
  Utrecht, Netherlands Recruiting

Study contacts

• Study coordinator: Evelyn Monninkhof, Dr.
• Email: e.monninkhof@umcutrecht.nl
• Phone: +31623786177

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.