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NCT Number: NCT06480513

Cancer Of the BReast Asanas Study (COBRA)

Rationale: Women with hormone-receptor positive breast cancer are usually prescribed endocrine therapy for a period of 5-10 years. This treatment reduces the risk of recurrence and improves overall survival in these women. Musculoskeletal complaints are a common (~50%) negative consequence of endocrine treatment, which affects daily functioning and quality of life. These symptoms frequently result in early treatment discontinuation, which is associated with shorter disease-free survival. Musculoskeletal complaints are often pharmacologically treated with limited effect and accompanied by side-effects. Therefore, interventions to counteract musculoskeletal complaints are urgently needed in this population. A potential non-pharmacological option is yoga. In patients with osteoarthritis, there is emerging evidence that yoga is effective to reduce pain and stiffness and improve function. Yoga as treatment for musculoskeletal complaints that are associated with endocrine treatment is rarely investigated and mainly in small studies.

Objective: The objective of the proposed study is to assess the effectiveness of a 4-month yoga program compared to a waiting list control group on musculoskeletal complaints in women with hormone-positive stage I-III breast cancer receiving endocrine treatment who report musculoskeletal complaints.

Study design: The COBRA study is a randomized controlled trial with two study arms: a yoga- and a waiting list control group.

Study population: For this study, 140 women with oestrogen-receptor positive stage I-III breast cancer on endocrine treatment (aromatase inhibitors or Tamoxifen; >4 months) will be recruited. These women experience musculoskeletal complaints (>3 months) which started or exacerbated after initiation of endocrine treatment. Furthermore, eligible women did not practice yoga in the last six months and are not planning to start yoga and are not highly physically active (i.e., >150 minutes per week moderate-vigorous exercise).

Intervention: The intervention consists of two one-hour sessions/week supervised yoga and once a week 30-minute yoga exercises at home. The 4-month yoga program will be an active form of yoga, such as Easy Vinyasa yoga, which is characterized by continuous slow movements linked with breathing. The waiting list control patients will be offered an online yoga program after the 4-month study period.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Utrecht (UMC Utrecht)

Utrecht, 85500 3508 GA, Netherlands

Location status: Recruiting

Location contact

Stefanie Veenhuizen, MSc

CONTACT

[email protected]

+31 6 31 11 91 29

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

live yoga

Behavioral

following live yoga classes twice a week and using yoga video's at home once a week

live remote yoga

Behavioral

The control group will be offered live remote yoga classes after the intervention period

Primary outcomes

  1. Musculoskeletal complaints

    Time frame: Baseline, at 4 and 8 months

    Worst of joint pain and stiffness/joint pain and stiffness severity/joint pain and stiffness interference assessed by the modified version of the BPI.

    The 14-item questionnaire result in three domain scores: worst pain/stiffness, pain/stiffness severity, and pain/stiffness interference over the past week, on a scale of 0 to 10. All these three domain scores of the BPI will be primary outcomes which will be tested sequentially to preserve an alpha of 0.05. The order of the sequential testing is: 1) worst pain/stiffness, 2) pain/stiffness severity and 3) pain/stiffness interference.

Secondary outcomes

  1. Lower extremity joint complaints

    Time frame: Baseline, at 4 and 8 months

    Using the WOMAC questionnaire

  2. Upper extremity musculoskeletal complaints

    Time frame: Baseline, at 4 and 8 months

    Using the DASH questionnaire

  3. Menopausal symptoms

    Time frame: Baseline, at 4 and 8 months

    Using the FACT-ES questionnaire

  4. Fatigue

    Time frame: Baseline, at 4 and 8 months

    Using the MFI questionnaire

  5. Sleep

    Time frame: Baseline, at 4 and 8 months

    Using the PSQI questionnaire

  6. Health-related Quality of Life (HRQoL)

    Time frame: Baseline, at 4 and 8 months

    Using the QLQ-C30 that has functional scales, symptom scales and a global quality of life (QOL) score. A high score for a functional scale represents a high/ healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

  7. Health-related quality of life (HRQoL)

    Time frame: Baseline, at 4 and 8 months

    Using the BR45. The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. All items are scored 1 to 4.

  8. Anxiety and depression

    Time frame: Baseline, at 4 and 8 months

    Using the Hospital Anxiety and Depression Scale (HADS) where anxiety and depression are measured separately on a scale from 0-7 (Normal), 8-10 (borderline abnormal) and 11-21 (abnormal).

  9. Cognitive functioning

    Time frame: Baseline and at 4 months

    Using the Amsterdam Cognition Scan

  10. Cognitive functioning

    Time frame: Baseline, at 4 and 8 months

    Using the FACT-COG

  11. Physical activity

    Time frame: Baseline, at 4 and 8 months

    Using the Short Questionnaire to Assess Health-enhancing physical activity (SQUASH). Physical activity is measured in minutes per week.

  12. Blood markers

    Time frame: Baseline and at 4 months

    Inflammatory markers (Interleukin-6 and Interleukin-IB, tumor necrosis factor alpha (TNF-alpha) and high-sensitive C-reactive protein (hsCRP). At the end of the study we will conduct a literature review to identify the most promising biomarkers.

  13. Physical strength

    Time frame: Baseline and at 4 months

    Hand grip strength using a handgrip dynamometer. The best of three attempts will be recorded.

  14. Physical strength

    Time frame: Baseline and at 4 months

    Leg press using a hypothetical 1-RM test

  15. Physical strength

    Time frame: Baseline and at 4 months

    Plank position holding time test for core strength

  16. Vital signs

    Time frame: Baseline and at 4 months

    Blood pressure and resting heart rate

  17. Anthropometrics

    Time frame: Baseline and at 4 months

    Weight and height will be combined to report BMI in kg/m^2. Waist- and hip circumference.

  18. Physical fitness

    Time frame: Baseline and at 4 months

    Steep ramp test using a cycle ergometer

  19. Physical fitness

    Time frame: Baseline and at 4 months

    Balance is measured with the Short-Form Fullerton Advanced Balance (S-FAB) scale. This scale consists of four items: stepping up onto and over a 6-inch bench, a tandem walk, standing on one leg, and standing on foam with the eyes closed. The items are rated from 0 (unable to complete the task) to 4 (completed the task perfectly), and the scores are summed up to a total score (0-16).

  20. Safety of the yoga intervention

    Time frame: 0-8 months (whole study period)

    (Serious) adverse events potentially related to the intervention

  21. Use of pain medication

    Time frame: 0-8 months (whole study period)

    Assessed with the BPI, questioned during the baseline and T1 visit, and self-reported with a diary

  22. Compliance with endocrine treatment

    Time frame: 0-8 months (whole study period)

    Self-reported with a diary

  23. Qualitative outcome

    Time frame: During or after the study

    Patient and teacher experiences with in-depth interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Evelyn Monninkhof, Dr.

CONTACT

[email protected]

+31623786177

Stefanie Veenhuizen, MSc

CONTACT

[email protected]

+31631119129

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • World Cancer Research Fund International

Registry information

Official study title

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

Acronym: COBRA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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