Clinical trial · Interventional
Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer.
Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer Who Will be Treated With Anthracyclines
NCT03027063CI-TRIAL-00049248completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is being done to determine whether exercise while receiving doxorubicin or Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this treatment on the heart and improve other outcomes related to cancer such as tumor markers, nausea, fatigue and the ability to tolerate chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adriamycin Toxicity | — | UNRESOLVED | — |
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10,000 steps | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 10,000 steps
- description
- For the "10,000 steps" group, participants will be asked to achieve a goal of 10,000 steps a day and to engage in 30 minutes of continuous exercise every day. Steps will be monitored with the under Armour fitness tracker which participants will receive. For motivation, messages will be sent to study participants in this group via the messaging center in the Under Armor application three times a week. The frequency of messaging will be increased for participants who fail to meet their goals for three consecutive days. Study participants will also receive a weekly call to assess for side effects and provide additional encouragement.
- interventionNames
- Behavioral: 10,000 steps
- type
- ACTIVE_COMPARATOR
- label
- Usual care
- description
- This will be the usual care group. Participants will also receive a fitness tracker to enable monitoring of steps and will be given a flyer that references the ACC/AHA guidelines for exercise and physical activity for the general population. Participants will not receive text messages or phone calls.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women who are 18 years and older * Women newly diagnosed with stage I to III breast cancer who will be receiving adjuvant or neoadjuvant doxorubicin-based chemotherapy * Women who will be treated at the Johns Hopkins Hospital, Sibley Memorial Hospital or who will be treated by oncologists in the community as long as we will have access to treatment records. * Women must be willing to receive follow up care either at Hopkins or with their local oncologist for at least 1 year. * Patients who are receiving therapy with an anthracycline. * Women who have a smart phone Exclusion Criteria: * Inability to exercise * Presence of metastatic disease * Advanced pulmonary disease as assessed by clinical symptoms of shortness of breath or known forced expiratory volume in 1 second \< 1 * Any patients requiring oxygen at baseline * The presence of known ischemic heart disease as defined by significant obstructive heart disease (stenosis \> 70%) seen on coronary angiography or cardiac CT * Abnormal baseline cardiac function defined as an ejection fraction of less than 55% * The presence of more than mild valvular stenosis or regurgitation, prosthetic valves or pacemaker on their baseline echocardiogram * Poor image quality on baseline echocardiogram or anatomic limitations that preclude the acquisition of good quality images such as recent mastectomy or surgery * Patients who do not have a smart phone onto which the Under Armour application can be downloaded * Patients who are unwilling to wear the Under Armour health band * Pregnancy * Previous anthracycline exposure * Rhythms other than sinus rhythm * Patients unwilling to come to the Johns Hopkins campus to have the required testing performed
References
Publications (0)
Data not yet available
No reference posted for this study.