Effect of exercise on cancer therapy related cardiac dysfunction in women with breast cancer undergoing chemotherapy

Not Applicable

Recruiting

• Conditions: Breast Cancer; Cardiovascular Disease; Hypertension; Type 2 Diabetes; Cancer - Breast; Cardiovascular - Hypertension; Metabolic and Endocrine - Diabetes; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621001030864
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-05
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Group 1:
- Female.
- 18 years of age or greater.
- Diagnosed with breast cancer and scheduled for anthracycline containing chemotherapy.
- No previous or current history of any other cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias.

Group 2:
- Female.
- 30-70 years of age.
- No previous or current history of any other cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias.
- No history of any cancer and no current cancer diagnosis

Exclusion Criteria

1) Previous or current history of cardiovascular disease including myocardial infarction, heart failure, coronary artery disease and arrhythmias. This DOES NOT include type 2 diabetes mellitus or hypertension.
2) A physical disability that prevents safe and adequate exercise testing and training.
3) Not meeting inclusion criteria listed above.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Global Longitudinal Strain (GLS) - images obtained via GE Vivid E95 Ultrasound.[Baseline, 1 month, 2 months (end of intervention - primary time point), 5 months (3 months after intervention completion)];Change in Left Ventricular Ejection Fraction (LVEF) - images obtained via GE Vivid E95 Ultrasound.[Baseline, 1 month, 2 months (end of intervention - primary time point), 5 months (3 months after intervention completion).]

Secondary Outcome Measures

Name	Time	Method
Change in Peak Oxygen Consumption (VO2 Peak) assessed via Parvomedics Trueone 2400 Metabolic Measurement System.[Baseline, 1 month, 2 months (end of intervention ), 5 months (3 months after intervention completion).];Quality of life assessed via EORTC QLQ-C30 ‘quality of life of cancer patients’ questionnaire.[Baseline, 1 month, 2 months (end of intervention), 5 months (3 months after intervention completion).];Fatigue assessed via EORTC QLQ-FA12 ‘cancer related fatigue’ questionnaire.[Baseline, 1 month, 2 months (end of intervention), 5 months (3 months after intervention completion).]