Stage IA Breast CancerNCT02454777
High-Intensity Interval Training for Stage I-III Breast Cancer Patients
A study testing Exercise Intervention, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer
- What is being tested?
- Exercise Intervention, Laboratory Biomarker Analysis and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2015to 15 Jul 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Being tested
- Exercise Intervention, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Undergo HIT
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| ARM I (HIT group) | Experimental | Participants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks. Receives: Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (Delayed group) | Active comparator | 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. Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
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.
Measured: Up to 17 weeks
Secondary outcomes (2)
Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)
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.
Measured: Baseline to up to week 17
Change in left ventricular function
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.
Measured: Baseline to up to week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study start29 Sep 2015
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Why it stopped: PI left
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 Stage IA Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christina Dieli-Conwright, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454777
- Sponsor's protocol ID
- 1B-14-5
- Other IDs
- NCI-2015-00579, 1B-14-5, P30CA014089
- Status last verified
- Apr 2021
- First submitted
- 21 May 2015
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34018031Lee 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.
PubMed 31269914Lee 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.
PubMed 31236810Lee 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.
PubMed 29961039
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use
- ClinicalTrials.gov ID
- NCT02454777
- Acronym / sponsor ID
- 1B-14-5
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Sep 2015 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 27 May 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.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM I (HIT group) | Experimental | Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks. |
| Arm II (Delayed group) | Active comparator | Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Exercise InterventionUndergo HIT | Behavioural | ARM I (HIT group) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | ARM I (HIT group), Arm II (Delayed group) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | ARM I (HIT group), Arm II (Delayed group) |
| Questionnaire AdministrationAncillary studies | Other | ARM I (HIT group), Arm II (Delayed group) |
Primary outcome
Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
Time frame: 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.
2 secondary outcomes
Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)
Time frame: Baseline to up to week 17
Change in left ventricular function
Time frame: Baseline to up to week 17
Results and safety
The study was stopped early (reason given: PI left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Derived from this study: PubMed 34018031Lee 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.
- Derived from this study: PubMed 31269914Lee 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.
- Derived from this study: PubMed 31236810Lee 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.
- Derived from this study: PubMed 29961039Lee 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.
- Individual participant dataSharing planned: Undecided
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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.
Christina Dieli-Conwright principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Stage IA Breast Cancer and Stage IB Breast Cancer, run by University of Southern California at 1 site in United States.
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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 Apr 2021. 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 United States. 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 was stopped early (reason given: PI left). Results are not available in the source record.
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 of utilizing HIT under clinical trial conditions, assessed using participant attendance rate (time frame: Up to 17 weeks). 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 NCT02454777, 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 5 Apr 2021.