High-Intensity Interval Training for Stage I-III Breast Cancer Patients
1. april 2021 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
31
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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California
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Los Angeles, California, Forente stater, 90033
- USC / Norris Comprehensive Cancer Center
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: ARM I (HIT group)
Participants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks.
|
Korrelative studier
Hjelpestudier
Andre navn:
Hjelpestudier
Undergo HIT
|
|
Aktiv komparator: 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.
|
Korrelative studier
Hjelpestudier
Andre navn:
Hjelpestudier
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
Tidsramme: 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.
|
Up to 17 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)
Tidsramme: 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
Tidsramme: Baseline to up to week 17
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christina Dieli-Conwright, University of Southern California
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. september 2015
Primær fullføring (Faktiske)
15. juli 2019
Studiet fullført (Faktiske)
15. juli 2019
Datoer for studieregistrering
Først innsendt
21. mai 2015
Først innsendt som oppfylte QC-kriteriene
21. mai 2015
Først lagt ut (Anslag)
27. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1B-14-5 (Annen identifikator: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH-stipend/kontrakt)
- NCI-2015-00579 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Plan for individuelle deltakerdata (IPD)
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Nei
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