Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy

Breast Cancer Clinical Trial

— HF-PROACTIVE  

Official title:

Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796365
• Other study ID #: HFHS-HF_PROACTIVE
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to identify patients at risk for future heart failure using novel markers of early cardiac damage and determine if exercise training can improve these emerging markers as well as overall fitness and quality of life.

Description:

With more than 14 million cancer survivors in the United States, more patients than ever are living well beyond their initial cancer diagnosis. However despite the tremendous progress, cancer treatments often come with adverse side-effects, perhaps none are more serious or devastating than chemotherapy induced heart failure.

In many patients, the clinical manifestation of heart failure may not appear until a year, or several years, after completion of chemotherapy. While an echocardiogram is part of standardized surveillance for patients on these drugs, current echocardiogram parameters may not be sensitive enough to quickly detect early heart damage which, in some cases, is irreversible.

Unfortunately, even if detected early, there is no uniformity in terms of how to best treat patients with subclinical cardiac dysfunction who are at risk for heart failure. The use of certain blood pressure drugs show promise, especially in patients with hypertension. However, in addition to drug side-effects (e.g. dizziness/lightheadedness), they do not target the underlying mechanism of chemotherapy induced cardiotoxicity.

Exercise, in various forms, has shown promise in animal studies as a potential cardio-protective therapy to counteract drug toxicity. In general, exercise has many pleiotropic effects for patients receiving chemotherapy (e.g. reduces fatigue, improves endurance, reduces frailty, and enhances quality of life). Relative to DOX toxicity, research involving animals has also shown that exercise protects against deleterious heart dysfunction while showing an enhancement of potential mechanisms involved in chemotherapy induced heart failure (i.e. anti-oxidant and anti-apoptosis pathways).

Patients with cancer who receive either doxorubicin (DOX) or trastuzumab will be screened by one of two methods: 1) a strain echo or 2) a high sensitivity troponin. If either test is positive, patients will meet with a board-certified cardiologist who will determine if the patient may participate in the exercise trial. Under the supervision of a trained clinical exercise physiologist patients will undergo baseline testing, which includes: a quality of life assessment via questionaires, a body composition test, cardiopulmonary stress test and a muscle strength test. These assessment will be performed at baseline and at 12 weeks. Also performed at 12 weeks will be a repeat strain echo and high sensitivity troponin.

Following baseline testing patients will be randomized into exercise training versus standard care. The exercise training will include 12 weeks of cardiac rehabilitation which can be offered in Detroit, Livonia, or West Bloomfield. Exercise will consist of 3 days per week of an interval training aerobic exercise on a treadmill and/or bike for 30-60 minutes and 1-2 days per week of an individualized resistance training program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with cancer who are undergoing or have completed the chemotherapy drugs doxorubicin and/or trastuzumab.

• Have had a recent echocardiogram with a relative reduction in LV strain of >10%.

• If no recent echocardiogram, have a troponin value >0.04 ng/mL, or an increase of 0.04 ng/mL if baseline troponin is elevated.

• Age >/= 18 years.

• Eastern Cooperative Oncology Group (ECOG) scale 0-2.

• Males and females.

Exclusion Criteria:

• Patients with an Ejection Fraction <50%

• Patients not deemed appropriate by a cardiologist or oncologist

• Patients with an ECOG scale >2

• Inability to perform exercise

• Patients who already report exercising >2days per week for >29 minutes

Related Conditions & MeSH terms

• Breast Cancer
• Cardiomyopathies
• Cardiotoxicity
• Doxorubicin Induced Cardiomyopathy
• Gastric Cancer
• Leukemia
• Stomach Neoplasms

Intervention

Other:
• Exercise
Intervention will include 10 weeks of a standard cardiac rehabilitation program consisting of thrice a week aerobic exercise and 1-2 days per week resistance exercises.

Locations

Country	Name	City	State
United States	William Clay Ford Center for Athletic Medicine	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Helen L. Kay Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular strain	Spectral Doppler measure with General Electric software analysis of global longitudinal strain.	12 weeks
Secondary	Peak VO2	During a graded treadmill test, breath-by-breath sampling of expired air will be measured using a MGC Diagnostics gas exchange analysis system.	12 weeks
Secondary	Percent body fat	Body fat will be analyzed using air displacement plethysmography (BodPod/Cosmed)	12 weeks
Secondary	Isokinetic strength	Peak torque will be measured using the Biodex Isokinetic dynamometer.	12 weeks
Secondary	Quality of life	Quality of life will be assessed using the Functional Assessment of Cancer Therapy (FACT-G).	12 weeks
Secondary	Cardiac Troponin	High sensitivity cardiac troponin will be analyzed using a commercial immunoassay.	12 weeks