Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer.

NCT03027063 | Completed

• 1 other identifier: IRB00110810
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Female; Adriamycin Toxicity

Keywords

Speckle tracking echocardiography

Outcome Measures

Primary Outcomes (1)

• Left ventricular dysfunction

  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.

  Change from baseline to up to 14 weeks

Secondary Outcomes (9)

• Cardiorespiratory fitness/peak oxygen consumption

  Up to 14 weeks

• Dual-energy x-ray absorptiometry

  Up to 14 weeks

• Quality of life as assessed by the Functional Assessment of Cancer Therapy-Breast Survey

  Up to 14 weeks

• Physical Activity as assessed by the Rapid Assessment of Physical Activity Questionnaire

  Up to 14 weeks

• Fatigue as assessed by the Multidimensional Fatigue Symptom Inventory-Short Form

  Up to 14 weeks

Study Arms (2)

10,000 steps

EXPERIMENTAL

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.

Behavioral: 10,000 steps

Usual care

ACTIVE COMPARATOR

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.

Behavioral: Usual Care

Interventions

10,000 steps BEHAVIORAL

Participants will be asked to achieve 10,000 steps daily and to participate in 30 minutes of continuous exercise of their choosing. They will also receive text messages during the week and weekly motivational call

10,000 steps

Usual Care BEHAVIORAL

Participants will receive the ACC/AHA exercise guidelines

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21218, United States

Location

Study Officials

• Roberta Florido, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)