Prevention Using Exercise Rehabilitation to Offset Cardiac Toxicities Induced Via Chemotherapy

NCT ID: NCT02796365

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-12-31

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 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.

Conditions

Doxorubicin Induced Cardiomyopathy; Breast Cancer; Gastric Cancer; Leukemia

Keywords

Exercise; Cancer; Cardiotoxicity; Cardiomyopathy; Cardiac Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

Usual care

Control group will not be instructed on exercise, but encouraged to follow standard medical advice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helen L. Kay Charitable Trust

UNKNOWN

Sponsor Role: collaborator

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Dennis J. Kerrigan

Bioscientific Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

William Clay Ford Center for Athletic Medicine

Detroit, Michigan, United States

Countries

United States

References

Kerrigan DJ, Reddy M, Walker EM, Cook B, McCord J, Loutfi R, Saval MA, Baxter J, Brawner CA, Keteyian SJ. Cardiac Rehabilitation Improves Fitness in Patients With Subclinical Markers of Cardiotoxicity While Receiving Chemotherapy: A RANDOMIZED CONTROLLED STUDY. J Cardiopulm Rehabil Prev. 2023 Mar 1;43(2):129-134. doi: 10.1097/HCR.0000000000000719. Epub 2022 Aug 4.

Reference Type: DERIVED

PMID: 35940850 (View on PubMed)

Other Identifiers

HFHS-HF_PROACTIVE

Identifier Type: -

Identifier Source: org_study_id