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Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study (EXACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471053
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Scott Grandy, Nova Scotia Health Authority

Brief Summary:

As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are becoming increasingly apparent. Most prominent are the toxic effects on the heart (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular disease (CVD). The investigators hypothesize that an individualized aerobic training program for cancer patients receiving active treatment will be both feasible and safe and will result in improvements in overall levels of physical activity and quality of life.

Feasibility will be assessed by evaluating the recruitment, adherence and attrition rates, along with program safety. Efficacy will be assessed by evaluating changes in health-related outcomes.


Condition or disease Intervention/treatment Phase
Neoplasms Heart; Disease, Functional Inflammation Other: Moderate Intensity Exercise Not Applicable

Detailed Description:

As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are becoming increasingly apparent. Most prominent are the toxic effects on the heart (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular disease (CVD). Of note, data indicate that the magnitude of CVD risk for long-term survivors may exceed the risk of a secondary malignancy, which is a known complication of primary cancer therapy. While long-term follow-up data in adult cancer survivors is lacking, study of adult survivors of childhood cancers shows that these individuals are 15 times more likely to develop congestive heart failure (CHF), 10 times more likely to develop CVD, and 9 times more likely to suffer a stroke compared individuals who have not had cancer. Thus, it is clear that the long-term cardiotoxic effects of cancer therapy represent a significant concern for cancer survivors. The mechanisms responsible for the damaging effects of cancer therapy are not fully understood, however there is a need to maximize the benefits of treatment while minimizing long-term damage. Recent animal studies suggest that aerobic exercise training may offer a protective effect against chemotherapy-induced heart disease. However, to the investigator's knowledge, no study to date has examined the potential cardioprotective benefits of exercise training for patients receiving cancer treatment.

Accordingly, the purpose of this pilot study is to evaluate the feasibility and efficacy of a 12-week supervised exercise program based on the principles of cardiac rehabilitation for patients receiving anthracycline-based chemotherapy.

Feasibility will be assessed by evaluating three outcomes, recruitment rate, adherence rate (i.e. exercise class attendance records), attrition rate, and safety (i.e. number of adverse events).

Efficacy will be assessed by evaluating changes in health-related outcomes to assess if these changes are equal to or better than what was measured at baseline. The health-related outcomes include cardiac function and biological markers of cardiotoxicity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study (EXACT)
Study Start Date : February 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderate Intensity Exercise
All consenting patients will participate in an aerobic training program, twice-weekly over a 12-week period. Assessments will be performed at baseline (pre-training) and post-program (12-weeks). All participants will continue to receive standard care for their cancer diagnosis.
Other: Moderate Intensity Exercise
Exercise sessions will be held twice-weekly and will begin with a group warm-up activity, followed by 45 minutes of aerobic activity and ending with a cool down. All aerobic exercise will be performed at a moderate intensity, defined as exercise that elicits a heart rate (HR) between 40-60% of heart rate reserve (HRR). Prior to the initial exercise session target heart rates will be calculated for each subject based on the maximum HR achieved during their baseline stress test.




Primary Outcome Measures :
  1. Feasibility as measured by rate of recruitment [ Time Frame: 12 Weeks ]
    The rate of recruitment will be measured by comparing the number of patients screened to the number of patients enrolled (patients per month).

  2. Number of adverse events [ Time Frame: 12 Weeks ]
    The number of adverse events associated with exercise program will be used to examine safety.


Secondary Outcome Measures :
  1. Feasibility as measured by program adherence [ Time Frame: 12 Weeks ]
    The program adherence will be calculated by dividing the total number of exercise sessions by the number of actual session attended.

  2. Feasibility as measured by attrition rate [ Time Frame: 12 Weeks ]
    The attrition rate will be measured by the number of patients who drop out of the study.

  3. Cardiac Function [ Time Frame: 12 Weeks ]
    Cardiac function will be measured by examining heart chamber size, ventricular function and blood flow between the cardiac chambers using a Multigated acquisition (MUGA) scan.

  4. Cardiac Disease Risk [ Time Frame: 12 Weeks ]
    Cardiac disease risk will be measured using the Framingham Risk Score.

  5. Aerobic Fitness [ Time Frame: 12 Weeks ]
    Aerobic fitness will be measured by comparing baseline and 12 week cardiac stress tests and the associated peak oxygen uptake values.

  6. Fatigue [ Time Frame: 12 Weeks ]
    The Functional Assessment of Cancer Therapy - Fatigue questionnaire will be used to compare baseline and 12 week self-reported levels of fatigue.

  7. Physical Activity Behaviours [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels of physical activity will be measured using the International Physical Activity Questionnaire.

  8. Quality of Life [ Time Frame: 12 Weeks ]
    The Functional Assessment of Cancer Therapy - General questionnaire along with the appropriate tumor specific appendix, will be used to compare baseline and 12 week quality of life measures.

  9. Lipid Profile [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels will be compared.

  10. Fasting Glucose [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels will be compared.

  11. High-sensitivity Troponin (hs-TNT) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels will be compared.

  12. N-terminal of the prohormone brain natriuretic peptide (NTproBNP) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels will be compared.

  13. C-reactive protein (CRP) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels will be compared.

  14. Cytokines (IL-1α) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels (picogram per milileter) will be compared.

  15. Cytokines (IL-1β) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels (picogram per milileter) will be compared.

  16. Cytokines (IL-4) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels (picogram per milileter) will be compared.

  17. Cytokines (IL-6) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels (picogram per milileter) will be compared.

  18. Cytokines (IL-10) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels (picogram per milileter) will be compared.

  19. Cytokines (IL-17) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels (picogram per milileter) will be compared.

  20. Cytokines (TNFα) [ Time Frame: 12 Weeks ]
    Baseline and 12 week levels (picogram per milileter) will be compared.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria - Only those patients who meet the following inclusion will be asked to participate in the study:

  • Between the ages of 18 and 65;
  • Receiving anthracycline chemotherapeutic treatment for a primary/non-recurrent breast or hematological malignancy;
  • Are scheduled to received a minimum dose of 100 mg/m2 of doxorubicin (DOX) or 120 mg/m2 of daunorubicin (DAUN), or 150 mg/m2 epirubicin (EPI)
  • Within eight weeks of first anthracycline dose;
  • Do not have a previous history of myocardial infarction, cerebrovascular disease, peripheral vascular disease, congestive heart failure, or cardiomyopathy (controlled hypertension is not exclusionary);
  • Have no known contraindications to light-to-moderate exercise;
  • Have no known contraindications to cardiopulmonary exercise stress testing;
  • Able to participate in the 12-week community-based exercise program;
  • Provided medical consent from their treating physician

Exclusion Criteria:

  • Any patients who meet the inclusion criteria, but have any significant cognitive limitations will be excluded from the study.

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): NCT02471053


Locations
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Canada, Nova Scotia
QEII Health Science Center, Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Scott Grandy, PhD Assistant Professor, Affiliate Scientist, Division of Cardiology, Nova Scotia Health Authority
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Scott Grandy, PhD, Assistant Professor, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02471053    
Other Study ID Numbers: EXACT2015
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Scott Grandy, Nova Scotia Health Authority:
Exercise
Quality of Life
Complementary Therapies
Neoadjuvant Therapy
Feasibility Studies
Additional relevant MeSH terms:
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Inflammation
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries