A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

Fatigue Clinical Trial

Official title:

A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms

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
• 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
• 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

Related Conditions & MeSH terms

• Dyssomnias
• Fatigue
• Parasomnias
• Sleep Disturbances

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