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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02360904
Other study ID # GCO 16-0656
Secondary ID 025-14
Status Completed
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date December 5, 2018

Study information

Verified date February 2019
Source Icahn School of Medicine at Mount Sinai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of this study is to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga and those not receiving yoga. Secondary endpoints will include other measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and adherence to yoga and to chemotherapy treatment.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 5, 2018
Est. primary completion date December 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age>18 years - History of stage I-III breast cancer - Patient scheduled to receive or within 2 weeks of receiving intravenous chemotherapy for their breast cancers - Eastern Cooperative Oncology Group Performance status of <3 - Ability to understand English 5.2 Exclusion Criteria: - Planning to start yoga on their own within the next 12 weeks - Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study - Severe chronic obstructive pulmonary disease - Class III or IV heart failure - Child C cirrhosis - End-Stage renal disease Exclusion Criteria: - Planning to start yoga on their own within the next 12 weeks - Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study - Severe chronic obstructive pulmonary disease - Class III or IV heart failure - Child C cirrhosis - End-Stage renal disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Yoga
The intervention will consist of 12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training. Classes will be conducted at the Beth Israel Comprehensive Cancer Center in a closed-group format, and will be offered twice a week. Yoga mats will be provided for each patient. The maximum number of patients attending each class will be 12. The classes will combine physical postures (asanas), breathing (pranayama), and deep relaxation (savasana). We would also encourage patient to practice yoga at home and keep a diary.

Locations

Country Name City State
United States Beth Israel Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in quality of life to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga immediately and those start yoga 3 months later. 12 weeks
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