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Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy (HF-PROACTIVE)

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ClinicalTrials.gov Identifier: NCT02796365
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Helen L. Kay Charitable Trust
Information provided by (Responsible Party):
Dennis J. Kerrigan, Henry Ford Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Doxorubicin Induced Cardiomyopathy Breast Cancer Gastric Cancer Leukemia Other: Exercise Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy
Study Start Date : June 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Exercise
Patients will participate in a 10 week outpatient cardiac rehabilitation program. Exercise will consist of 3 days per week of interval training on a treadmill or bike at an intensity between 50-90% of heart rate reserve. Additionally patients will perform resistance exercises 1-2 days per week and attend 8 nutrition and lifestyle classes.
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.

No Intervention: Usual care
Control group will not be instructed on exercise, but encouraged to follow standard medical advice.



Primary Outcome Measures :
  1. Left ventricular strain [ Time Frame: 12 weeks ]
    Spectral Doppler measure with General Electric software analysis of global longitudinal strain.


Secondary Outcome Measures :
  1. Peak VO2 [ Time Frame: 12 weeks ]
    During a graded treadmill test, breath-by-breath sampling of expired air will be measured using a MGC Diagnostics gas exchange analysis system.

  2. Percent body fat [ Time Frame: 12 weeks ]
    Body fat will be analyzed using air displacement plethysmography (BodPod/Cosmed)

  3. Isokinetic strength [ Time Frame: 12 weeks ]
    Peak torque will be measured using the Biodex Isokinetic dynamometer.

  4. Quality of life [ Time Frame: 12 weeks ]
    Quality of life will be assessed using the Functional Assessment of Cancer Therapy (FACT-G).

  5. Cardiac Troponin [ Time Frame: 12 weeks ]
    High sensitivity cardiac troponin will be analyzed using a commercial immunoassay.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796365


Locations
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United States, Michigan
William Clay Ford Center for Athletic Medicine
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Helen L. Kay Charitable Trust

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Responsible Party: Dennis J. Kerrigan, Bioscientific Staff, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02796365     History of Changes
Other Study ID Numbers: HFHS-HF_PROACTIVE
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dennis J. Kerrigan, Henry Ford Health System:
Exercise
Cancer
Cardiotoxicity
Cardiomyopathy
Cardiac Rehabilitation

Additional relevant MeSH terms:
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Cardiomyopathies
Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries