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High-Intensity Interval Training for Stage I-III Breast Cancer Patients

1. april 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • USC / Norris Comprehensive Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ARM I (HIT group)
Participants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks.
Andet: Laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: Livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • Livskvalitetsvurdering
Andet: Spørgeskemaadministration
Hjælpestudier
Adfærdsmæssigt: Exercise Intervention
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.
Andet: Laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: Livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • Livskvalitetsvurdering
Andet: Spørgeskemaadministration
Hjælpestudier

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Foranstaltningsbeskrivelse
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
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.
Baseline to up to week 17
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.
Baseline to up to week 17

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Southern California

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Christina Dieli-Conwright, University of Southern California

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. september 2015

Primær færdiggørelse (Faktiske)

15. juli 2019

Studieafslutning (Faktiske)

15. juli 2019

Datoer for studieregistrering

Først indsendt

21. maj 2015

Først indsendt, der opfyldte QC-kriterier

21. maj 2015

Først opslået (Skøn)

27. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1B-14-5 (Anden identifikator: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH-bevilling/kontrakt)
  • NCI-2015-00579 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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