Exercise to Prevent AnthraCycline-based Cardio-Toxicity Study 2.0 (EXACT2)

NCT03748550 | Active Not Recruiting

• 1 other identifier: 1024489
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

Although great progress has been made in treating breast cancer, long-term health may be impaired by cancer therapy. For example, some chemotherapy drugs (e.g., anthracyclines) are known to cause declines in heart health. While the impact can vary, some will experience substantial heart damage that may lead to heart failure and death. As these treatments are highly effective, there is a need to find ways to reduce the damaging effects while not interfering with its anticancer potential. As it is well-known that regular exercise can improve heart health, the purpose of this study is to explore the role of exercise as a heart protective therapy for breast cancer patients receiving heart damaging chemotherapy.

Conditions

Cancer, Breast; Cardiotoxicity; Cardiovascular Diseases

Keywords

Anthracyclines; Cardiotoxic; Breast cancer; Aerobic exercise; Cardiac structure; Cardiac function; CVD risk

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular (LV) Function

  LV function will be assessed using serial transthoracic echocardiography (TTE) as well as tissue velocity imaging (TVI) and strain imaging (SI.) For 2-dimensional (2D) LV cavity dimensions and LVEF will be determined from the acquired 2D images according to established criteria. Tissue Doppler-derived indexes will be recorded at the base of the lateral mitral annuli to determine longitudinal endocardial velocities. The indexes that will be assessed are systolic (S'), early diastolic (e') and late diastolic (a') velocities. Doppler-independent strain will be assessed offline using semi-automated speckle tracking techniques. These will be performed using parasternal and apical views to determine both global longitudinal and radial strain.

  LV function will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.

Secondary Outcomes (5)

• Change in Cardiac Electrical Activity

  The cardiac ECG will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.

• Change in Aerobic Fitness

  Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.

• Change in Blood biomarkers

  Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.

• Change in Functional Assessment for Cancer Therapy

  Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.

• Change in Fatigue

  Outcome will be assessed at baseline (week 0), post-intervention (week-13) and 6 months after the completion of the intervention.

Study Arms (2)

Control

NO INTERVENTION

Participants will receive standard of care treatment for their breast cancer.

Exercise

EXPERIMENTAL

Participants will receive standard of care treatment for their breast cancer plus be given a 12-week home based aerobic exercise program.

Behavioral: Aerobic exercise

Interventions

Aerobic exercise BEHAVIORAL

All participants will receive standard of care for their cancer as well as given a 12-week, home-based progressive aerobic exercise (AE) program. A nonlinear progressive training approach will be used whereby each participant will perform two AE sessions (e.g. walking), on non-consecutive days, per week. AE sessions will vary between low (35-45% heart rate reserve (HRR)), low-moderate (46-55% HRR), high-moderate (56-70% HRR) and high (71-85% HRR) intensity.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) must be 18 years or older.
• diagnosed with breast cancer (stages I-III) and not have started therapy.
• must be scheduled to receive AC- based chemotherapy (minimum dose of 240 mg/m2 of DOX or 300 mg/m2 of DAN).
• are able to undertake a 12-week home-based, progressive aerobic exercise program.
• have medical clearance from a cardiologist (e.g. based on stress test results) to participate in the study.

You may not qualify if:

• significant cognitive limitations.
• pre-existing medical condition that would otherwise contraindicate aerobic exercise.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Canadian Cancer Society (CCS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V8, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinicians interpreting the echocardiograms and stress test results will not know whether the participant is in the control group or the exercise intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to either the standard of care group (control) or the intervention group (standard of care + 12-weeks aerobic exercise).

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 21, 2018
• Study Start: April 29, 2019
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)