Cancer Of the BReast Asanas Study (COBRA)

NCT06480513 | Recruiting

• 1 other identifier: 24-054/G; NL86325.041.24
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Musculoskeletal complaints

  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.

  Baseline, at 4 and 8 months

Secondary Outcomes (23)

• Lower extremity joint complaints

  Baseline, at 4 and 8 months

• Upper extremity musculoskeletal complaints

  Baseline, at 4 and 8 months

• Menopausal symptoms

  Baseline, at 4 and 8 months

• Fatigue

  Baseline, at 4 and 8 months

• Sleep

  Baseline, at 4 and 8 months

Study Arms (2)

yoga group

EXPERIMENTAL

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

Behavioral: live yoga

control group

OTHER

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

Behavioral: live remote yoga

Interventions

live yoga BEHAVIORAL

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

yoga group

live remote yoga BEHAVIORAL

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

control group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• World Cancer Research Fund International: collaborator

Study Sites (1)

University Medical Center Utrecht (UMC Utrecht)

Utrecht, 85500 3508 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne May, Prof. Dr.

  UMC Utrecht

  STUDY DIRECTOR

Central Study Contacts

Evelyn Monninkhof, Dr.

CONTACT

+31623786177; e.monninkhof@umcutrecht.nl

Stefanie Veenhuizen, MSc

CONTACT

+31631119129; s.g.a.veenhuizen@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 28, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

NL (1)