Exercise Preconditioning and Breast Cancer Cardiotoxicity (EXACCT)
Aerobic Interval Exercise Preconditioning to Prevent Cardiometabolic and Neuropsychological Complications of Anthracycline Based Breast Cancer Chemotherapy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The primary aim of this study is to determine the efficacy of a novel, high-intensity aerobic interval exercise preconditioning protocol to ameliorate anthracycline-mediated cardiac and skeletal muscle toxicity in women with breast cancer undergoing de novo chemotherapy.
Research Design:
Women with breast cancer scheduled to undergo de novo chemotherapy with anthracyclines will be enrolled. Qualified patients will be randomized to either 1) a high-intensity interval exercise group, or 2) an attention-control group.
Supervised exercise training will be carried out at the Mayo Clinic Cardiac rehabilitation center in Arizona on cycle ergometers using Electrocardiogram (EKG) telemetry. Patients in the high-intensity interval exercise group will perform four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR.
The attention-controls will receive counseling consistent with standard of care regarding physical activity during chemotherapy. Attention-control group will receive a weekly phone call to maintain physical activity during chemotherapy and compliance will be verified using physical activity diaries and pedometers.
Treatment for each group will commence 1-week prior to chemotherapy induction. The first dose of chemotherapy will be given within 16-18 hours of the last bout of exercise. High-intensity intermittent exercise (HIIE) training will be continued throughout four, 2-week cycles of chemotherapy (total training time = 9 weeks, 3 days/week).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Arizona
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Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic in Arizona
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent
- Subjects will have been recently diagnosed with breast cancer (stage I, II or III)
- Subjects must be scheduled by their oncologist to undergo anthracycline based chemotherapy (doxorubicin and cyclophosphamide) in the neoadjuvant/adjuvant setting
Exclusion Criteria:
- Unstable angina
- Myocardial infarction in the past 4 weeks
- Uncompensated heart failure
- New York Heart Association class IV symptoms
- Complex ventricular arrhythmias
- Medical orthopedic conditions precluding stationary cycling
- Medical conditions precluding neuropsychological assessment
- Symptomatic severe aortic stenosis
- Acute pulmonary embolus
- Acute myocarditis
- Untreated high-risk proliferative retinopathy
- Recent retinal hemorrhage
- Uncontrolled hypertension
- Sodium and/or Potassium ≥ Grade 2
- Pregnant Women
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: A high-intensity interval exercise group
Supervised exercise training with be carried out at the Mayo Clinic Cardiac rehabilitation center on cycle ergometers using EKG telemetry.
Treatment will begin one week prior to chemotherapy and is tailored around 8 weeks.
|
To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
|
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Annen: An attention-control group
Patients will receive counseling regarding physical activity during chemotherapy.
Patients will receive a weekly phone call to maintain physical activity during chemotherapy and compliance will be verified using physical activity diaries and pedometers.
|
Patients will be contacted weekly to access physical activity.
To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in left ventricular ejection fraction
Tidsramme: baseline, approximately 2 months
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Echocardiography will be used to assess biventricular systolic function.
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baseline, approximately 2 months
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Change in diastolic function
Tidsramme: baseline, approximately 2 months
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Echocardiography will be used to assess biventricular diastolic function.
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baseline, approximately 2 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Farouk Mookadam, MBBCh, Mayo Clinic
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15-004656
Plan for individuelle deltakerdata (IPD)
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