Cardio-Oncology Rehabilitation Exercise

Breast Cancer Clinical Trial

— CORE  

Official title:

A Single Arm Intervention Study to Assess the Role of Structured Cardio-Oncology Rehabilitation Exercise to Improve Cardiovascular Health in Early Stage Breast Cancer Survivors (CORE Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522959
• Other study ID #: 19-5080
• Status: Recruiting
• Start date: March 14, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Toronto
• Contact: Amy A Kirkham, PhD
• Phone: (416) 946-4069??
• Email: amy.kirkham[@]utoronto.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of early-stage breast cancer (I-III)
• Currently receiving or have completed adjuvant therapy (i.e. chemotherapy, surgery, radiation, targeted therapies)
• Able to communicate in English

Exclusion Criteria:

• Pregnancy
• Metastatic disease (Stage IV)
• Unable or unwilling to complete cardiopulmonary exercise test

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Toronto Rehabilitation Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Smoking Status	Smoking assessment history questionnaire	post-intervention (16 weeks)
Other	Moderate-Intensity Physical Activity Time	PiezoRx® will be worn by participants for 7 days with data used to assess moderate activity time (>100 steps per minute)	averaged over 7 days post-intervention
Other	Vigorous-intensity Physical Activity	PiezoRx® will be worn by participants for 7 days with data used to assess vigorous activity time (>120 steps per minute)	averaged over 7 days post-intervention
Other	Physical Activity Bouts per Day	PiezoRx® will be worn by participants for 7 days with data used to assess bouts of physical activity per day (greater than 10 minutes of moderate/vigorous activity)	averaged over 7 days post-intervention
Other	Total daily steps	PiezoRx® will be worn by participants for 7 days with data used to assess total daily steps	averaged over 7 days post-intervention
Other	Self-Reported Physical Activity	Godin Leisure Time Physical Activity Questionnaire	post-intervention (16 weeks)
Other	Diet quality	Rapid Eating and Activity Assessment for Participants (REAP) questionnaire. Minimum score = 13, maximum score = 39, with a higher score indicating a higher diet quality.	post-intervention (16 weeks)
Primary	Cardiopulmonary Fitness	VO2peak assessed using cardiopulmonary exercise test	post-intervention (16 weeks)
Secondary	Visceral adipose tissue	Measured only in a subset (n=30) of participants via 1.5T MRI.	post-intervention (16 weeks)
Secondary	Left ventricular ejection fraction	Measured only in a subset (n=30) of participants via 1.5T MRI.	post-intervention (16 weeks)
Secondary	Native myocardial T1 time	Measured only in a subset (n=30) of participants via 1.5T MRI.	post-intervention (16 weeks)
Secondary	Left ventricular mass	Measured only in a subset (n=30) of participants via 1.5T MRI.	post-intervention (16 weeks)
Secondary	lipid profile	Assessed via fasting blood draw	post-intervention (16 weeks)
Secondary	Fasting glucose	Assessed via fasting blood draw	post-intervention (16 weeks)
Secondary	hemoglobin A1c	Assessed via fasting blood draw	post-intervention (16 weeks)
Secondary	Cancer-specific, health-related quality of life	Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 108, with higher score representing better quality of life.	post-intervention (16 weeks)
Secondary	Depressive symptoms	Patient Health Questionnaire 9 scale. Minimum value = 0, maximum value = 27, where higher score represents more depressive symptoms.	post-intervention (16 weeks)
Secondary	Psychosocial Stress	Perceived Stress Scale (PSS). Minimum value = 0, maximum value = 56, where higher score represents more perceived stress.	post-intervention (16 weeks)
Secondary	Cancer-related fatigue	Fatigue sub-scale of the Functional Assessment of Cancer Therapy (FACT) questionnaire. Minimum score = 0, maximum score = 52, with higher score representing less fatigue.	post-intervention (16 weeks)