Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480513
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-12
Brief Title:
Cancer Of the BReast Asanas COBRA Study
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
The Effect of Yoga on Endocrine Therapy Induced Musculoskeletal Symptoms in Women With Breast Cancer the COBRA Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COBRA
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 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 ie 150 minutes per week moderate-vigorous exercise
Intervention The intervention consists of two one-hour sessionsweek 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
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 ie 150 minutes per week moderate-vigorous exercise
Intervention The intervention consists of two one-hour sessionsweek 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None