High-Intensity Interval Training for Stage I-III Breast Cancer Patients
1 april 2021 bijgewerkt door: University of Southern California
High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use
This randomized pilot clinical trial studies the feasibility of high-intensity interval training in improving cardiovascular fitness in patients with stage I-III breast cancer undergoing chemotherapy with trastuzumab.
Trastuzumab helps patients live longer, but may cause side effects to the heart.
Aerobic exercise may help the heart function better, which may help protect it against side effects from trastuzumab.
Exercise may also help reduce fatigue and prevent cancer from coming back.
High-intensity interval training involves short bursts of higher intensity efforts with longer periods of recovery.
This may also allow patients who cannot exercise for a long period of time to still be physically active.
This trial studies whether patients can tolerate high-intensity interval training, and how well it works in improving fitness in patients with breast cancer receiving trastuzumab.
Studie Overzicht
Toestand
Beëindigd
Conditie
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. To assess the feasibility (completion of > 80% exercise sessions) of utilizing high-intensity interval training (HIT).
II. To determine the effects of HIT on aerobic exercise adaptation when compared to delayed group.
III. To examine the effects of HIT on left ventricular function when compared to delayed group.
IV. To determine the effects of HIT on endothelial function, arterial stiffness, and vascular atherosclerosis when compared to delayed group.
OUTLINE: Participants are randomized to 1 of 2 groups.
ARM I: HIT (High-intensity Interval Training) group - Participants undergo HIT over 30 minutes, thrice weekly for 8 weeks.
ARM II: DEL (Delayed/usual care) group - Participants maintain their current sedentary activity level (< 60 minutes of total exercise per week) for 8 weeks. Participants document their weekly activity in an exercise log. Following completion of all study visits, participants are given the option to complete the HIT exercise program as in Arm I.
After completion of study, patients are followed up at weeks 9 and 17.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
31
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90033
- USC / Norris Comprehensive Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- English or Spanish speaking
- Diagnosed with early stage (I-III) breast cancer, without evidence of metastatic disease
- Planned (neo)adjuvant therapy with trastuzumab (Herceptin) and/or anthracycline-based chemotherapy
- Not currently pregnant or planning to become pregnant throughout the duration of cancer treatment
- Physician (oncologist) clearance to participate in exercise at moderate to high intensity
- Have read and signed study informed consent document (ICF)
- EXERCISE INCLUSION CRITERIA:
- Normal body temperature (=< 100 degrees F)
- Resting blood pressure and/or heart rate within normal limits
- Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Exclusion Criteria:
- Advanced stage (stage IV) or metastatic breast cancer diagnosis (screening for metastases with scans only needed if there is clinical suspicion for metastases)
- Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
- Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc.)
- Moderate to highly active level of physical activity (e.g. currently participating in >= 60 minutes of moderate aerobic activity weekly)
- Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
- EXERCISE EXCLUSION CRITERIA:
- Presence of fever (>= 100 degrees F)
- Resting blood pressure and/or heart rate outside normal limits
- Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: ARM I (HIT group)
Participants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks.
|
Correlatieve studies
Nevenstudies
Andere namen:
Nevenstudies
Undergo HIT
|
|
Actieve vergelijker: Arm II (Delayed group)
Participants maintain their current sedentary activity level (< 60 minutes of total exercise per week) for 8 weeks.
Participants document their weekly activity in an exercise log.
Following completion of all study visits, participants are given the option to complete the HIT program as in Arm I.
|
Correlatieve studies
Nevenstudies
Andere namen:
Nevenstudies
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
Tijdsspanne: Up to 17 weeks
|
The exercise program will be considered feasible if participants complete greater than 80% of exercise sessions.
Participant attendance rates will be used to establish compliance and will be used to provide a perspective on how and to what extent cancer patients will participate in an experimental exercise intervention and what variations in exercise intensities may be tolerated.
Feasibility will be assessed based on both program attendance as well as exercise time completed.
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Up to 17 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)
Tijdsspanne: Baseline to up to week 17
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A mixed-effect regression model will be fit to compare the mean changes in VO2peak (ml/kg/min) between groups.
The effect of other covariates such as the menopausal age, severity of disease and the class of chemotherapy treatment and compliance rate on VO2peak (ml/kg/min) over time will also be examined.
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Baseline to up to week 17
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Change in left ventricular function
Tijdsspanne: Baseline to up to week 17
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A mixed-effect model will be fit to compare the mean changes in left ventricular ejection fraction, left ventricular end-diastolic volume, left ventricular end-systolic volume, and peak filling time.
The effect of other covariates such as the menopausal age, severity of disease and the class of chemotherapy treatment and compliance rate on left ventricular function over time will also be examined.
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Baseline to up to week 17
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Christina Dieli-Conwright, University of Southern California
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Lee K, Norris MK, Wang E, Dieli-Conwright CM. Effect of high-intensity interval training on patient-reported outcomes and physical function in women with breast cancer receiving anthracycline-based chemotherapy. Support Care Cancer. 2021 Nov;29(11):6863-6870. doi: 10.1007/s00520-021-06294-7. Epub 2021 May 20.
- Lee K, Kang I, Mack WJ, Mortimer J, Sattler F, Salem G, Dieli-Conwright CM. Feasibility of high intensity interval training in patients with breast Cancer undergoing anthracycline chemotherapy: a randomized pilot trial. BMC Cancer. 2019 Jul 3;19(1):653. doi: 10.1186/s12885-019-5887-7.
- Lee K, Kang I, Mack WJ, Mortimer J, Sattler F, Salem G, Lu J, Dieli-Conwright CM. Effects of high-intensity interval training on vascular endothelial function and vascular wall thickness in breast cancer patients receiving anthracycline-based chemotherapy: a randomized pilot study. Breast Cancer Res Treat. 2019 Sep;177(2):477-485. doi: 10.1007/s10549-019-05332-7. Epub 2019 Jun 24.
- Lee K, Kang I, Mortimer JE, Sattler F, Mack WJ, Fitzsimons LA, Salem G, Dieli-Conwright CM. Effects of high-intensity interval training on vascular function in breast cancer survivors undergoing anthracycline chemotherapy: design of a pilot study. BMJ Open. 2018 Jun 30;8(6):e022622. doi: 10.1136/bmjopen-2018-022622.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
29 september 2015
Primaire voltooiing (Werkelijk)
15 juli 2019
Studie voltooiing (Werkelijk)
15 juli 2019
Studieregistratiedata
Eerst ingediend
21 mei 2015
Eerst ingediend dat voldeed aan de QC-criteria
21 mei 2015
Eerst geplaatst (Schatting)
27 mei 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 april 2021
Laatste update ingediend die voldeed aan QC-criteria
1 april 2021
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1B-14-5 (Andere identificatie: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2015-00579 (Register-ID: CTRP (Clinical Trial Reporting Program))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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