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| Name | Class |
|---|---|
| NRG Oncology | OTHER |
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The investigators seek to conduct a home based exercise intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to determine whether breast cancer patients can be enrolled, randomized, retained, and comply with exercise program; and, the feasibility of acquiring, managing and analyzing clinical data.
Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that aerobic exercise training is safe during primary adjuvant therapy and improves cardiopulmonary function and patient related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular specific mortality in women. Specifically, an increase in cardiopulmonary fitness of approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is important as breast cancer patients already present at diagnosis with 31% lower cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of exercise prescriptions that incorporate high intensity aerobic exercise training in cancer patients, especially those receiving chemotherapy. Therefore, the investigators seek to conduct an at home aerobic exercise training intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | We ask that participants in the control arm do not start an exercise program. | |
| Exercise | Experimental | Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence. Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity. The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study. | Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study. | 4 weeks |
| Participant Adherence to the Exercise Intervention | Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor. | Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion) |
| Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection | Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline. | Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline) |
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3.1 Inclusion Criteria
3.2 Exclusion Criteria
Absolute contraindications for exercise stress testing
Non-English speaking
Women only diagnosed with ductal carcinoma in situ
Women diagnosed with stage 4 metastatic breast cancer
Pregnant women
Men
Children
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Sturgeon, PhD | Assistant Professor, Penn State | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35216638 | Result | Sturgeon KM, Smith AM, Federici EH, Kodali N, Kessler R, Wyluda E, Cream LV, Ky B, Schmitz KH. Feasibility of a tailored home-based exercise intervention during neoadjuvant chemotherapy in breast cancer patients. BMC Sports Sci Med Rehabil. 2022 Feb 25;14(1):31. doi: 10.1186/s13102-022-00420-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | We ask that participants in the control arm do not start an exercise program. |
| FG001 | Exercise | Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence. Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level. Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity. The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | We ask that participants in the control arm do not start an exercise program. |
| BG001 | Exercise | Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence. Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level. Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity. The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study. | Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study. |
| Posted | Count of Participants | Participants | 4 weeks |
|
Approximately 9 months, from consent to final testing.
Systematic review of EMR for serious adverse events, systematic use of injury history questionnaire at follow up testing. The injury history questionnaire contains self-report for all adverse events that are specific and non-specific to exercise training. The "at Risk" population for "Other (Not Including Serious) Adverse Events" is reflective of women that completed the questionnaire at follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | We ask that participants in the control arm do not start an exercise program. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis/embolism | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
The study was closed to recruitment at n=19, 1 patient short of anticipated enrollment (n=20) due to the COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Sturgeon | Penn State University | 7175314530 | 284676 | kms99@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2022 | Mar 16, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 21, 2019 | Mar 16, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Participants are randomized to the intervention or control arm.
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|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Participant Adherence to the Exercise Intervention | Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor. | The control group was not given heart rate monitors or an exercise prescription. | Posted | Mean | Standard Error | % exercise time at prescribed heart rate | Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion) |
|
|
|
| Primary | Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection | Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline. | Patients that withdrew, were lost to follow up, or developed treatment-induced contraindications to exercise testing, are not included in the analysis population. | Posted | Mean | Standard Deviation | ml/kg/min | Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline) |
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|
| 0 |
| 10 |
| 5 |
| 10 |
| 4 |
| 7 |
| EG001 | Exercise | Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence. Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level. Exercise: All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity. The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max. | 0 | 9 | 5 | 9 | 4 | 7 |
| Allergic reaction | Immune system disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Cardiac palpitations | Cardiac disorders | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | Systematic Assessment |
|
| cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
|