Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study

NCT02471053 | Completed

• 1 other identifier: EXACT2015
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Heart; Disease, Functional; Inflammation

Keywords

Exercise; Quality of Life; Complementary Therapies; Neoadjuvant Therapy; Feasibility Studies

Outcome Measures

Primary Outcomes (2)

• Feasibility as measured by rate of recruitment

  The rate of recruitment will be measured by comparing the number of patients screened to the number of patients enrolled (patients per month).

  12 Weeks

• Number of adverse events

  The number of adverse events associated with exercise program will be used to examine safety.

  12 Weeks

Secondary Outcomes (20)

• Feasibility as measured by program adherence

  12 Weeks

• Feasibility as measured by attrition rate

  12 Weeks

• Cardiac Function

  12 Weeks

• Cardiac Disease Risk

  12 Weeks

• Aerobic Fitness

  12 Weeks

Study Arms (1)

Moderate Intensity Exercise

EXPERIMENTAL

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

Interventions

Moderate Intensity Exercise OTHER

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.

Moderate Intensity Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

QEII Health Science Center, Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (4)

• Albini A, Pennesi G, Donatelli F, Cammarota R, De Flora S, Noonan DM. Cardiotoxicity of anticancer drugs: the need for cardio-oncology and cardio-oncological prevention. J Natl Cancer Inst. 2010 Jan 6;102(1):14-25. doi: 10.1093/jnci/djp440. Epub 2009 Dec 10.

  PMID: 20007921 BACKGROUND

• Yeh ET. Cardiotoxicity induced by chemotherapy and antibody therapy. Annu Rev Med. 2006;57:485-98. doi: 10.1146/annurev.med.57.121304.131240.

  PMID: 16409162 BACKGROUND

• Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185.

  PMID: 17035650 BACKGROUND

• Keats MR, Grandy SA, Giacomantonio N, MacDonald D, Rajda M, Younis T. EXercise to prevent AnthrCycline-based Cardio-Toxicity (EXACT) in individuals with breast or hematological cancers: a feasibility study protocol. Pilot Feasibility Stud. 2016 Aug 5;2:44. doi: 10.1186/s40814-016-0084-9. eCollection 2016.

  PMID: 27965861 DERIVED

MeSH Terms

Conditions

Neoplasms; Disease; Inflammation; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Scott Grandy, PhD

  Assistant Professor, Affiliate Scientist, Division of Cardiology, Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant Professor

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: June 12, 2015
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)