Cancer Of the BReast Asanas (COBRA) Study
NCT Number: NCT06480513
Acronym: COBRA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: BEHAVIORAL: live yoga|BEHAVIORAL: live remote yoga
Sponsor: UMC Utrecht
Collaborators: World Cancer Research Fund International
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2027-01

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.

Primary Outcome Measures: 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, Baseline, at 4 and 8 months
Secondary Outcome Measures: Lower extremity joint complaints, Using the WOMAC questionnaire, Baseline, at 4 and 8 months|Upper extremity musculoskeletal complaints, Using the DASH questionnaire, Baseline, at 4 and 8 months|Menopausal symptoms, Using the FACT-ES questionnaire, Baseline, at 4 and 8 months|Fatigue, Using the MFI questionnaire, Baseline, at 4 and 8 months|Sleep, Using the PSQI questionnaire, Baseline, at 4 and 8 months|Quality of Life, 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., Baseline, at 4 and 8 months|Quality of Life, 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., Baseline, at 4 and 8 months|Anxiety and depression, 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)., Baseline, at 4 and 8 months|Cognitive problems, Using the Amsterdam Cognition Scan, Baseline and at 4 months|Cognitive problems, Using the FACT-COG, Baseline, at 4 and 8 months|Habitual physical activity, Using the Short Questionnaire to Assess Health-enhancing physical activity (SQUASH). Physical activity is measured in minutes per week., Baseline, at 4 and 8 months|Blood markers, 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., Baseline and at 4 months|Physical strength, Hand grip strength using a handgrip dynamometer. The best of three attempts will be recorded., Baseline and at 4 months|Physical strength, Leg press using a hypothetical 1-RM test, Baseline and at 4 months|Physical fitness, Steep ramp test using a cycle ergometer, Baseline and at 4 months|Vital signs, Blood pressure and resting heart rate, Baseline and at 4 months|Anthropometrics, Weight and height will be combined to report BMI in kg/m\^2. Waist- and hip circumference., Baseline and at 4 months|Safety of the yoga intervention, (Serious) adverse events potentially related to the intervention, 0-8 months (whole study period)|Use of pain medication, Self-reported with a diary, 0-8 months (whole study period)|Compliance with endocrine treatment, Self-reported with a diary, 0-8 months (whole study period)