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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.

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.

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

Participants will receive the ACC/AHA exercise guidelines

Usual Care

Roberta Florido, MD

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.

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.

For motivation, messages will be sent to study participants in group 2 via the messaging center in the Under Armour application three times a week. With the application, study participant will receive a phone alert and an email message to which they may respond if needed. The frequency of messaging will be increased for participants who fail to meet their goals for three consecutive days. In addition to the Under Armour application, participants will be provided with a log sheet for recording their daily steps, whether 30 minutes of continuous activity daily was completed and the type of the activity done for the 30 minutes. Group two study subjects will also receive a weekly call to assess for side effects and provide additional encouragement. Log sheets will be collected during oncology clinic visits and the aforementioned intervention will be continued for the duration of their chemotherapy treatment. Group 1 study participants will be assessed for side effects through a phone call every 4 weeks.

For the study, women will be given an Under Armour band that will monitor daily steps, amount of sleep and heart rate. Participants will be asked to download the Under Armour application to their mobile phones so the data from their bands can be synced with the application daily. For the intervention, study subjects will be asked to achieve a goal of 10,000 steps a day and to engage in 30 minutes of continuous exercise every day and this can be any form of exercise.

All patients who agree to participate will be invited to the Johns Hopkins Hospital medical campus where all the testing will be performed. The investigators expect to complete the study in 9 months.

Study participants who agree to participate will have the following assessments performed at baseline:

1. A Cardiopulmonary Exercise Stress Test done using the standard protocol and supervised by an exercise physiologist.
2. A 2D echocardiogram. The echocardiogram will include assessment of strain using speckle tracking and tissue Doppler and the determination of systolic ejection time. All patients routinely have an echocardiogram performed prior to the initiation of cardio-toxic chemotherapy such as doxorubicin (Adriamycin), trastuzumab (Herceptin) and pertuzumab (Perjeta), however, for the study, strain analysis will be performed off line on the images obtained during the clinically indicated baseline echocardiogram. Echocardiograms will be performed by experienced sonographers and on the same model echo machine to reduce variability.
3. Bone densitometry assessment via a Dual-energy X-ray absorptiometry to measure total and regional body composition in the frontal plane to determine bone, fat and fat-free mass. The Dual-energy X-ray absorptiometry scan takes about 8-10 minutes. The total radiation dose is approximately 1 millirem, which is very small.
4. Muscle strength will be measured using a hand grip tool.
5. Habitual activity levels will be assessed using the Rapid Assessment of Physical Activity questionnaire, which categorizes activity levels on a scale from 1-7 (sedentary to active).
6. Quality of life will be assessed with the Functional Assessment of Cancer Therapy-Breast survey
7. Fatigue level will be performed with the Multidimensional Fatigue Symptom Inventory-Short Form
8. All patients routinely have blood work collected, and as part of this research protocol, the investigators will also collect blood to determine baseline tumor markers ( high-sensitivity C-reactive protein, Insulin-like growth factor 1, interleukin -6, interleukin-1 and tumor necrosis factor alpha, leptin, adiponectin, estradiol, DNA extraction, lymphocyte telomere length) and cardiac biomarkers (high sensitivity troponin, troponin, pro-brain natriuretic peptide). The investigators will also collect and store blood in order to keep open the possibility of doing a more extensive study to look at any future genes that might be related to the phenotypes in this study (cancer, cardiomyopathy, exercise response, etc.).
9. Cardiac history will be obtained at recruitment, including clinical risk factors for heart disease (hypertension, diabetes and smoking history) and participants will be evaluated throughout the study for any cardiac symptoms especially those of Heart failure.

All of the above assessments will all be performed at baseline and repeated within 2 weeks of the women completing their anthracycline-based chemotherapy. The investigators will also track the clinical echocardiograms obtained at 12 months, but these results are not required for the study.

Other studies: Serum troponin levels will be checked with each cycle of chemotherapy. Height will be measured upon recruitment and weight and blood pressure will be measured at the time of each echocardiogram.

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

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.

Cardiorespiratory fitness/peak oxygen consumption measured using a metabolic stress test

Dual-energy x-ray absorptiometry scan will be performed using standard procedures

Functional Assessment of Cancer Therapy-Breast survey will be administered upon completion of therapy to assess for change in quality of life. Each question on the questionnaire ranges from 0 to 4. The least score is 0 and the maximum is 148 points. Higher scores indicate a higher quality of life.

Change in physical activity with the intervention will be assessed by the Rapid Assessment of Physical Activity questionnaire. This is scored from 1 to 7 with 7 being the most active.

Multidimensional Fatigue Symptom Inventory-Short Form will be used to assess for change in fatigue. Scores for each question range from 0 to 4. The maximum total fatigue score is 72. The higher the score, the more fatigued one is.

Analysis will be performed to assess the impact that receiving motivational text messages has on increasing the amount of physical activity performed/number of daily steps achieved.

Analysis will be performed to assess the impact of weekly telephone calls on increasing the amount of physical activity/number of daily steps achieved

Analysis will be performed to assess the impact that engaging in 30 minutes of daily exercise has on increasing the amount of physical activity performed/number of daily steps achieved

Difference in troponin levels in the the two groups post treatment

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Cyclophosphamide

The CT with Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + OV nutritional supplement.

The QT Adriamycin scheme 60 mg per m2 of Body Surface (SC) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles + a placebo of the OV nutritional supplement.

The included patients received the Ocoxin-Viusid nutritional supplement at a rate of 75 ml daily (25 ml in 3 doses every 8 hours) administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment\* and up to three weeks after the end of the treatment.

\*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center.

CT + Ocoxin-Viusid

The included patients received the OV placebo in oral solution at a rate of 75 ml daily (25 ml in 3 doses every 8 hours), administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment\* and up to three weeks after the end of the treatment.

\*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center.

CT + Placebo

The purpose is to determine the efficacy of the nutritional supplement Ocoxin-Viusid oral solution (OV) in the reduction of acute toxicity of Chemotherapy (CT) treatment with patients with breast carcinoma. A randomized, double-blind phase II clinical trial was designed, with a sample of 120 patients distributed in 2 arms: 60 patients will receive the CT treatment plus the OV, 60 will receive CT plus OV placebo. The OV / placebo will be administered before, during and 3 weeks after the conclusion of the CT. A better tolerance to the treatment is expected with the addition of the nutritional supplement.

To obtain the sample size, the proportion of patients presenting adverse reactions that require interrupting chemotherapy treatment will be taken into account. In the institution, this figure is close to 15%. Since it is a dietary supplement, with extensive information on the safety of the product, the design is used in a stage of Flemming (without early stop rules). Assuming that the Ocoxin-Viusid product would clearly be declared ineffective (maximal ineffectiveness) if the proportion of patients not presenting adverse reactions was equal to less than 85% (p0), that is the maximum level of success below which the product does not shows signs of efficacy (the study does not guarantee further research) and taking a p1 value of 95%, where p1 is the minimum level of efficacy required from which the product would be declared effective (the results guarantee to continue a study phase III). Assuming an α error of 5% (probability of rejecting the null hypothesis when it is true) and β (probability of rejecting the alternative hypothesis when it is true) of 20% (the power of the test: 1 - β = 80%), It is determined to recruit a maximum number of 59 - 60 subjects. Determine a = 54, where a is the number of responses equal and below which the product is declared ineffective (H0 is accepted). And r = a + 1 is the cut-off point, that is, the number of responses from which the efficacy level ensures to continue to a phase III study. In this case we would expect to obtain a number of successes ≥ 55.

Patients will be randomized after surgery, in the chemotherapy consultation, and once they meet the established inclusion criteria. In order to achieve the masking of the research product, these have been labeled by a balanced randomized list obtained by computer, which will be in the possession of the Biostatistician of the study of the Clinical Investigations Section of INOR and the promoter. The product under study has been consecutively labeled from 1 to 120 (60 patients in each therapeutic arm).

Phase II randomized, controlled, double blind clinical trial.

A double blind. The masking will be maintained until the analysis of the data. However, access to the code will be allowed if serious adverse events arise related to the research product.

Evaluation of Ocoxin®-Viusid® in Breast Cancer

Efficacy of Ocoxin-Viusid in the Prevention of Acute Toxicity by Chemotherapy in Patients With Breast Cancer. Phase II Clinical Trial

The effect of the treatment will be evaluated from the number of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.

Dichotomous variable that will be evaluated through the answer yes or no. In cases of negative response, the cause of non-compliance will be collected. It will be collected in the evaluation corresponding to each cycle of chemotherapy and in the final evaluation.

The effect of the treatment will be evaluated from the percentage of interruptions of oncospecific treatment due to acute toxic reactions to chemotherapy.

It will be measured through the Karnofsky Index. The Karnofsky Index will be collected in each evaluation query (score of 0-100 points at intervals of 10).

It will be measured through quality of life scale of the EORTC QLQ-C30 (general). It's a questionnaire of 30 questions divided into 3 areas: Functional capacity (physical aspect, social role, cognitive capacity, emotional and social factors; yes or no), symptoms (asthenia, pain and nausea / vomiting; from 1 to 4) and global assessment (from 1 to 10)

It will be measured through quality of life scale of the EORTC QLQ-BR23 (specific for breast cancer), it contains 31-53 questions, with a scale from 1-4 or 1-7 (bad-excellent):

-Functional scales:

Body image (BRBI) Sexual functioning (BRSEF) Sexual enjoyment (BRSEE) Future perspective (BRFU)

-Symptom scales / items

Systemic therapy side effects (BRST) Breast symptoms (BRBS) Arm symptoms (BRAS) Upset by hair loss (BRHL)

It will be determined through the Body Mass Index (BMI). The investigator must take into account that if the patient presents with ascites, she should indicate a paracentesis (whenever possible and the type of ascites allows it) before measuring her body weight.

It will be determined through the value of total proteins and albumin.

The safety of the treatment will be determined through the reporting of adverse events that are presented to the research product.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer.	NCT03027063	Breast Cancer F... Adriamycin Toxi...	10,000 steps Usual Care	18 Years -	Johns Hopkins University
Impact of Exercise on Mitigating the Cardio-toxic Effects of Adriamycin Among Women Newly Diagnosed With Breast Cancer.	NCT03027063	Breast Cancer F... Adriamycin Toxi...	10,000 steps Usual Care	18 Years -	Johns Hopkins University
Evaluation of Ocoxin®-Viusid® in Breast Cancer	NCT03576521	Breast Cancer Breast Carcinom... Adriamycin Toxi... Cyclosporine To...	CT + Ocoxin-Viu... CT + Placebo	18 Years -	Catalysis SL

Spots Global Cancer Trial Database for adriamycin toxicity