Cancer Of the BReast Asanas (COBRA) Study

Trial Title: Cancer Of the BReast Asanas (COBRA) Study

NCT ID: NCT06480513

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: live yoga
Description: following live yoga classes twice a week and using yoga video's at home once a week
Arm group label: yoga group

Intervention type: Behavioral
Intervention name: live remote yoga
Description: The control group will be offered live remote yoga classes after the intervention period
Arm group label: control group

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; >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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Be diagnosed with oestrogen-receptor positive stage I-III breast cancer, - Use of aromatase inhibitors (>4 months and will continue using it for at least six months), - Have finished primary treatment (chemotherapy, radiotherapy, surgery) for at least six 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(19), 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 2 weeks not able to attend training sessions during the intervention period

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Start date: September 2024

Completion date: January 2027

Lead sponsor:
Agency: UMC Utrecht
Agency class: Other

Collaborator:
Agency: World Cancer Research Fund International
Agency class: Other

Source: UMC Utrecht

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06480513