Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer Who Will be Treated With Anthracyclines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Left ventricular dysfunction
研究概览
简要总结
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.
详细描述
This will be a pilot study that looks at the effect of exercise, while receiving anthracycline therapy, on mitigating the cardio toxic effects of anthracyclines as assessed by serial echocardiographic strain analysis.
Potential participants will be identified during chart review in advance of a routine clinic visit or during a routine clinic visit with a provider. Individuals will be approached by the provider or study team to determine willingness to learn more about a study for which they may be eligible. Discussions regarding study participation will take place privately and individuals will be provided with the Institutional Review Board (IRB) approved consent form.
In addition, potential participants may contact the study team directly. This contact may be in the form of telephone, email, etc. Initial discussions regarding study participation may take place by phone, email, etc., and individuals may be provided with the IRB approved consent form and other IRB reviewed and approved materials (e.g., Patient Handout), as applicable.
In all cases, as much time as is needed to consider study participation will be allowed to possible participants; resulting in multiple phone calls, visits, emails, or other communication, as necessary. For individuals who choose to take part, informed consent will happen as per the consent process.
Patients will be recruited from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Sibley Memorial Hospital and the community. The investigators anticipate that among roughly 60 subjects approached for enrollment, 30 will be part of the final study. Participants who agree to participate will be asked to provide written consent. Participants will be randomized by an online system to one of the following two groups in a 1:2 ratio. Group 1(Usual care group) will receive a fitness tracker and flyers that reference the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise and physical activity for the general population. In addition to fitness tracker and flyers, Group 2 (10,000 steps group) will receive additional messages and phone calls for motivation. This group of participants will also be asked to take part in 30 minutes of continuous exercise daily as part of their intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Left ventricular dysfunction
时间窗: Change from baseline to up to 14 weeks
Development of left ventricular dysfunction, assessed by echocardiogram and defined as a decrease in global longitudinal strain between the baseline echocardiogram and the echocardiogram obtained post-treatment with an anthracycline.
次要结局
- Dual-energy x-ray absorptiometry(Up to 14 weeks)
- Impact of engaging in 30 minutes of exercise on increasing the amount of physical activity(Up to 14 weeks)
- Cardiorespiratory fitness/peak oxygen consumption(Up to 14 weeks)
- Physical Activity as assessed by the Rapid Assessment of Physical Activity Questionnaire(Up to 14 weeks)
- Serum Troponin(Change from baseline to up to 14 weeks)
- Quality of life as assessed by the Functional Assessment of Cancer Therapy-Breast Survey(Up to 14 weeks)
- Impact of motivational messages on increasing the amount of physical activity(Up to 14 weeks)
- Impact of telephone calls on increasing the amount of physical activity(Up to 14 weeks)
- Fatigue as assessed by the Multidimensional Fatigue Symptom Inventory-Short Form(Up to 14 weeks)