Clinical Trial: Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy

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.

Detailed Summary:

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 eithe
Sponsor: Henry Ford Health System

Current Primary Outcome: Left ventricular strain [ Time Frame: 12 weeks ]

Spectral Doppler measure with General Electric software analysis of global longitudinal strain.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • Percent body fat [ Time Frame: 12 weeks ]
    Body fat will be analyzed using air displacement plethysmography (BodPod/Cosmed)
  • Isokinetic strength [ Time Frame: 12 weeks ]
    Peak torque will be measured using the Biodex Isokinetic dynamometer.
  • Quality of life [ Time Frame: 12 weeks ]
    Quality of life will be assessed using the Functional Assessment of Cancer Therapy (FACT-G).
  • Cardiac Troponin [ Time Frame: 12 weeks ]
    High sensitivity cardiac troponin will be analyzed using a commercial immunoassay.


Original Secondary Outcome: Same as current

Information By: Henry Ford Health System

Dates:
Date Received: April 29, 2016
Date Started: June 2016
Date Completion: June 2018
Last Updated: June 9, 2016
Last Verified: June 2016