Yoga intervention for women with hormone-receptor positive breast cancer

The Effect of Yoga on Endocrine Therapy Induced Musculoskeletal Symptoms in Women With Breast Cancer: the COBRA Study

This study tests whether yoga can help women with hormone-receptor positive breast cancer feel less pain and stiffness while improving their overall quality of life during treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sex: Female
• Sponsor: UMC Utrecht (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Utrecht)
• Trial ID: NCT06480513 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women diagnosed with estrogen-receptor positive stage I-III breast cancer who have been on aromatase inhibitors for at least four months and are experiencing musculoskeletal complaints.

Not a fit: Patients who are too physically active or those who have recently participated in structured yoga classes may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life for women undergoing endocrine therapy for breast cancer by reducing musculoskeletal complaints.

How similar studies have performed: While yoga has shown promise in managing pain and improving function in other conditions, its application specifically for musculoskeletal complaints related to endocrine therapy in breast cancer patients is relatively novel.

Eligibility criteria

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 this trial is running

Utrecht

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

Study contacts

• Study coordinator: Evelyn Monninkhof, Dr.

Conditions Breast Cancer