This randomized pilot clinical trial studies how well daily exercise works in reducing side effects of doxorubicin hydrochloride (Adriamycin) in patients with stage I-III breast cancer who are receiving anthracyclines. Complete daily exercise when receiving anthracycline therapy for breast cancer may reduce the cardio-toxic effects of anthracyclines on the heart and may improve other cancer specific outcomes such as tumor markers, nausea, fatigue and the ability to tolerate chemotherapy.
Additional locations may be listed on ClinicalTrials.gov for NCT03027063.
See trial information on ClinicalTrials.gov for a list of participating sites.
RPIMARY OBJECTIVES:
I. To determine whether the mean number of steps achieved daily, as measured by a fitness tracker, impacts the change in echocardiographic strain observed on serial echocardiograms obtained at baseline and after the administration of 4 cycles of doxorubicin (Adriamycin) based therapy.
SECONDARY OBJECTIVES:
I. Assess the added value of text messaging, phone calls and encouraging 30 minutes of continuous exercise on helping women increase their physical activity and daily steps achieved.
II. To assess the impact of differing amounts of exercise, while receiving chemotherapy, on cardiorespiratory fitness measured by cardiopulmonary exercise stress test (CPET), body composition determined by dual-energy X-ray absorptiometry (DEXA), quality of life measured by the Functional Assessment of Cancer Therapy-Breast survey, physical activity assessed by the Rapid Assessment of Physical Activity questionnaire and fatigue as determined by the Multidimensional Fatigue Symptom Inventory-Short Form.
III. To assess the effect that different amounts of exercise will have on cardiac biomarkers measured at different point and on tumor biomarkers.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive flyers on the current American College of Cardiology/American Heart Association (ACC/AHA) recommendations for daily exercise during treatment with an anthracycline.
GROUP II: Patients complete 10,000 steps daily and engage in 30 minutes of continuous exercise daily. Patients receive ACC/AHA flyers as in Group I and also receive additional motivation to exercise via text messages and phone calls during the treatment with an anthracycline.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal Investigatorseth martin