An interventional study of Exercise in Breast Neoplasm and Physical Activity, sponsored by Milton S. Hershey Medical Center. Completed at 2 sites in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care
Among 21 studies in Breast Neoplasms by Milton S. Hershey Medical Center — none open to participants now, none under way, none of them phase 3. Breast Neoplasms · Milton S. Hershey Medical Center.
Among the 21 studies in Breast Neoplasms by Milton S. Hershey Medical Center, this one is the 9th largest by enrollment of the 19 interventional ones that give a count, is one of 4 that started in 2017, is one of 13 with no phase, and was the 11th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →None of the 21 studies in Breast Neoplasms by Milton S. Hershey Medical Center is open now. The open studies under Breast Neoplasms, anywhere →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 21 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 19 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 18 across the 19 interventional studies, 106 across the 2 observational. Of the 15 that completed or were terminated, 5 (33%) have results posted.
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Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 21 studies in Breast Neoplasms by Milton S. Hershey Medical Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
3.2 Exclusion Criteria
Absolute for exercise stress testing
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
We ask that participants in the control arm do not start an exercise program.
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.
Behavioral: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)
| Milestone | Control | Exercise |
|---|---|---|
| Started | 10 | 9 |
| Completed | 9 | 8 |
| Not completed | 1 | 1 |
Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
| Participants | All Eligible Individuals |
|---|---|
| Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study. | 19 |
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.
| % exercise time at prescribed heart rate | Control | Exercise |
|---|---|---|
| Introduction phase | — | 72.7 ± 11.5 |
| Intermediate phase | — | 61.0 ± 5.0 |
| Maintenance phase | — | 23.7 ± 7.1 |
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.
| ml/kg/min | Control | Exercise |
|---|---|---|
| Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection | -27.5 ± 7.4 | -1.0 ± 13.2 |
Collected over Approximately 9 months, from consent to final testing.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/10 (0%) | 5/10 (50%) | 4/7 (57.1%) |
| Exercise | 0/9 (0%) | 5/9 (55.6%) | 4/7 (57.1%) |
| Event | Control | Exercise |
|---|---|---|
| Allergic reactionImmune system disorders | 0/10 | 1/9 |
| Renal failureRenal and urinary disorders | 0/10 | 1/9 |
| respiratory distressRespiratory, thoracic and mediastinal disorders | 0/10 | 1/9 |
| Febrile neutropeniaInfections and infestations | 0/10 | 1/9 |
| Chest painCardiac disorders | 1/10 | 1/9 |
| AnemiaBlood and lymphatic system disorders | 0/10 | 1/9 |
| Thrombosis/embolismVascular disorders | 1/10 | 0/9 |
| Cardiac palpitationsCardiac disorders | 1/10 | 0/9 |
| NeuropathyNervous system disorders | 1/10 | 0/9 |
| cholecystitisHepatobiliary disorders | 1/10 | 0/9 |
| Event | Control | Exercise |
|---|---|---|
| Muscle painMusculoskeletal and connective tissue disorders | 1/7 | 2/7 |
| DizzinessNervous system disorders | 2/7 | 1/7 |
| Joint PainMusculoskeletal and connective tissue disorders | 1/7 | 1/7 |
| Chest painCardiac disorders | 1/7 | 1/7 |
| NauseaGastrointestinal disorders | 1/7 | 0/7 |
| Age, Continuous(years) | Control | Exercise | Total |
|---|---|---|---|
| Mean | 51.5 ± 9.5 | 47.0 ± 11.7 | 49.4 ± 10.5 |
| Sex: Female, Male(Participants) | Control | Exercise | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Control | Exercise | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 9 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Exercise | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 8 | 5 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2017 to primary completion in Dec 2020, 40 months.
Results were first posted in May 2023, 2 years 5 months after primary completion.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 40 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center →