NeoplasmsEXACTNCT02471053
Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study
A study testing Moderate Intensity Exercise in people with Neoplasms and Heart; Disease, Functional, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neoplasms, Heart; Disease, Functional, Inflammation
- What is being tested?
- Moderate Intensity Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any patients who meet the inclusion criteria, but have any significant cognitive limitations will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
QEII Health Science Center, Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7
About this study
Official title: Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study (EXACT)
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.
Read the 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.
- Conditions
- Neoplasms, Heart; Disease, Functional, Inflammation
- Being tested
- Moderate Intensity Exercise
- Keywords
- Exercise, Quality of Life, Complementary Therapies, Neoadjuvant Therapy, Feasibility Studies
- Medical subject headings
- Neoplasms, Disease, Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Moderate Intensity Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 Weeks
Number of adverse events
The number of adverse events associated with exercise program will be used to examine safety.
Measured: 12 Weeks
Secondary outcomes (20)
Feasibility as measured by program adherence
The program adherence will be calculated by dividing the total number of exercise sessions by the number of actual session attended.
Measured: 12 Weeks
Feasibility as measured by attrition rate
The attrition rate will be measured by the number of patients who drop out of the study.
Measured: 12 Weeks
Cardiac Function
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.
Measured: 12 Weeks
Cardiac Disease Risk
Cardiac disease risk will be measured using the Framingham Risk Score.
Measured: 12 Weeks
Aerobic Fitness
Aerobic fitness will be measured by comparing baseline and 12 week cardiac stress tests and the associated peak oxygen uptake values.
Measured: 12 Weeks
Fatigue
The Functional Assessment of Cancer Therapy - Fatigue questionnaire will be used to compare baseline and 12 week self-reported levels of fatigue.
Measured: 12 Weeks
Physical Activity Behaviours
Baseline and 12 week levels of physical activity will be measured using the International Physical Activity Questionnaire.
Measured: 12 Weeks
Life Quality
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.
Measured: 12 Weeks
Lipid Profile
Baseline and 12 week levels will be compared.
Measured: 12 Weeks
Fasting Glucose
Baseline and 12 week levels will be compared.
Measured: 12 Weeks
High-sensitivity Troponin (hs-TNT)
Baseline and 12 week levels will be compared.
Measured: 12 Weeks
N-terminal of the prohormone brain natriuretic peptide (NTproBNP)
Baseline and 12 week levels will be compared.
Measured: 12 Weeks
C-reactive protein (CRP)
Baseline and 12 week levels will be compared.
Measured: 12 Weeks
Cytokines (IL-1α)
Baseline and 12 week levels (picogram per milileter) will be compared.
Measured: 12 Weeks
Cytokines (IL-1β)
Baseline and 12 week levels (picogram per milileter) will be compared.
Measured: 12 Weeks
Cytokines (IL-4)
Baseline and 12 week levels (picogram per milileter) will be compared.
Measured: 12 Weeks
Cytokines (IL-6)
Baseline and 12 week levels (picogram per milileter) will be compared.
Measured: 12 Weeks
Cytokines (IL-10)
Baseline and 12 week levels (picogram per milileter) will be compared.
Measured: 12 Weeks
Cytokines (IL-17)
Baseline and 12 week levels (picogram per milileter) will be compared.
Measured: 12 Weeks
Cytokines (TNFα)
Baseline and 12 week levels (picogram per milileter) will be compared.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Grandy, Nova Scotia Health Authority
- Investigators
- Scott Grandy, PhD, Principal investigator, Assistant Professor, Affiliate Scientist, Division of Cardiology, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471053
- Sponsor's protocol ID
- EXACT2015
- Acronym
- EXACT
- Status last verified
- Dec 2022
- First submitted
- 11 May 2015
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20007921Yeh ET. Cardiotoxicity induced by chemotherapy and antibody therapy. Annu Rev Med. 2006;57:485-98. doi: 10.1146/annurev.med.57.121304.131240.
PubMed 16409162Oeffinger 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.
PubMed 17035650Keats 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.
PubMed 27965861
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study (EXACT)
- ClinicalTrials.gov ID
- NCT02471053
- Acronym / sponsor ID
- EXACT / EXACT2015
- Conditions
- Neoplasms, Heart; Disease, Functional, Inflammation
- Keywords
- Exercise, Quality of Life, Complementary Therapies, Neoadjuvant Therapy, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Exercise | Experimental | Other: Moderate Intensity ExerciseAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Any patients who meet the inclusion criteria, but have any significant cognitive limitations will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Intensity ExerciseExercise 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. | Other | Moderate Intensity Exercise |
Primary outcome
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).
Number of adverse events
Time frame: 12 Weeks
The number of adverse events associated with exercise program will be used to examine safety.
20 secondary outcomes
Feasibility as measured by program adherence
Time frame: 12 Weeks
Feasibility as measured by attrition rate
Time frame: 12 Weeks
Cardiac Function
Time frame: 12 Weeks
Cardiac Disease Risk
Time frame: 12 Weeks
Aerobic Fitness
Time frame: 12 Weeks
Fatigue
Time frame: 12 Weeks
Physical Activity Behaviours
Time frame: 12 Weeks
Life Quality
Time frame: 12 Weeks
Lipid Profile
Time frame: 12 Weeks
Fasting Glucose
Time frame: 12 Weeks
High-sensitivity Troponin (hs-TNT)
Time frame: 12 Weeks
N-terminal of the prohormone brain natriuretic peptide (NTproBNP)
Time frame: 12 Weeks
C-reactive protein (CRP)
Time frame: 12 Weeks
Cytokines (IL-1α)
Time frame: 12 Weeks
Cytokines (IL-1β)
Time frame: 12 Weeks
Cytokines (IL-4)
Time frame: 12 Weeks
Cytokines (IL-6)
Time frame: 12 Weeks
Cytokines (IL-10)
Time frame: 12 Weeks
Cytokines (IL-17)
Time frame: 12 Weeks
Cytokines (TNFα)
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Background: PubMed 20007921Albini 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.
- Background: PubMed 16409162Yeh ET. Cardiotoxicity induced by chemotherapy and antibody therapy. Annu Rev Med. 2006;57:485-98. doi: 10.1146/annurev.med.57.121304.131240.
- Background: PubMed 17035650Oeffinger 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.
- Derived from this study: PubMed 27965861Keats 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Grandy, PhD principal investigator
Assistant Professor, Affiliate Scientist, Division of Cardiology, Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Exercise in people with Neoplasms and Heart; Disease, Functional, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by rate of recruitment (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471053, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.