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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
University Medical Center Utrecht (UMC Utrecht)
RECRUITING
Utrecht
Contact Information
Primary
Evelyn Monninkhof, Dr.
e.monninkhof@umcutrecht.nl
+31623786177
Backup
Stefanie Veenhuizen, MSc
s.g.a.veenhuizen@umcutrecht.nl
+31631119129
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2027-01
Participants
Target number of participants: 140
Treatments
Experimental: yoga group
following live yoga classes twice a week and using yoga video's at home once a week
Other: control group
Waiting list control group. The control group will be offered live remote yoga classes after the intervention period
Related Therapeutic Areas
Sponsors
Collaborators: World Cancer Research Fund International
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov