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Bortezomib

Proteasome Inhibitors

The purpose of this study is to learn more about how a drug commonly used to treat multiple myeloma can affect the heart.

In this study, the investigators will learn whether a drug called how a drug (called bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part of the standard treatment and its effects on multiple myeloma is not being studied here.

The investigators want to learn whether damage occurs to the heart after taking bortezomib for multiple myeloma, whether it is reversible, and we can predict damage to the heart before it occurs.

Whole blood and serum for batch analysis. Once the assays have been completed, the samples will be discarded.

Evaluation of Cardiotoxic Effects of Bortezomib

Prospective Assessment of the Cardiac Effects the Proteasome Inhibitor Bortezomib in Patients Undergoing Therapy for Multiple Myeloma

Millennium: The Takeda Oncology Company

Oregon Health and Science University

Assistant Professor of Medicine

Skin and Connective Tissue Diseases

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Acute Graft Versus Host Disease

Doxorubicin

Liposomal doxorubicin

an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post

no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines

An acute bout of exercise performed 24 hours prior to every anthracycline infusion.

exercise

Kristin L Campbell, PhD

In rodents, a single bout of exercise prior to injection of a chemotherapy agent used to treat breast cancer prevents or attenuates a number of markers of cardiac injury. This study will investigate whether this finding translates to human breast cancer patients. Participants scheduled to receive chemotherapy for breast cancer will be randomized to exercise or no exercise 24 hours prior to every chemotherapy treatment. The effect on cardiac function will be compared between groups noninvasively by echocardiography and electrocardiography and a venous blood draw at baseline before chemotherapy, after the first treatment and at the end of chemotherapy.

1. Purpose The purpose of this study is to investigate whether performing a single bout of exercise 24 hours prior to receiving infusions of the anthracycline chemotherapy agent doxorubicin for breast cancer can prevent some of the damaging cardiac effects. Currently, doxorubicin is the most effective chemotherapy agent for breast cancer but is also the most damaging. As such, increased risk of cardiovascular disease is a growing concern in doxorubicin-treated patients. Current strategies for minimizing cardiac injury are dose reduction and discontinuation of therapy, which compromise the effectiveness of the treatment. Interventions that can minimize the cardiac injury associated with doxorubicin could reduce cancer-related and cardiovascular disease-related mortality in women diagnosed with breast cancer.
2. Hypotheses 1. Performing an acute bout of exercise within 24 hours before anthracycline infusion will decrease the acute negative change in subclinical markers of cardiotoxicity after the first anthracycline infusion seen in those who do not exercise for 72 hours prior.

2. Performing exercise within 24 hours before every infusion of anthracycline will decrease the negative change in markers of cardiac dysfunction seen at the end of chemotherapy in those who do not exercise for 72 hours prior to each infusion.

3) Justification An acute exercise bout prior to induction of a myocardial infarction in animals provides cardioprotective benefit by reducing the size of the infarct relative to control animals. Recently, acute exercise performed 24 hours before anthracycline injection in rodents has also provided a cardioprotective benefit. Oxidative stress and apoptosis of cardiomyocyte mitochondria are primary mechanisms of anthracycline-induced cardiotoxicity. The single acute bout of exercise prevented or attenuated some of the anthracycline-induced negative effects on cardiomyocytes including oxidative stress, apoptosis, mitochondrial dysfunction, as well as systolic dysfunction. There are no studies to date that have investigated the cardiac effects of an acute bout of exercise in close proximity to anthracycline infusion in humans. Aerobic exercise training is recommended throughout chemotherapy treatment, but there are no guidelines in place in terms of the timing of exercise in relation to receipt of chemotherapy infusions.

4) Objectives

1. To compare the acute effect of performing exercise (within 24 hours before the first infusion) compared to no exercise (no exercise for 72 hours prior to the first infusion) on markers of subclinical cardiotoxicity 24-48 hours after the first anthracycline infusion.
2. To compare the chronic effect of performing exercise (within 24 hours before every infusion) compared to no exercise (no exercise for 72 hours prior to every infusion) on markers of cardiotoxicity 7 to 14 days after the final anthracycline infusion 5) Research Method This study will be a two-arm randomized control trial. Twenty-four women aged 18 or older newly diagnosed with stage I-IIIA breast cancer, and scheduled to receive neoadjuvant or adjuvant doxorubicin chemotherapy in cycles of 2-3 weeks will be recruited by oncologist referral and posters. Participants will be randomized to one of two conditions: i) an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post; or ii) no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines.

6) Statistical Analysis The primary outcome will be global longitudinal strain measured by echocardiography. The secondary outcomes will be the NT-proBNP and cardiac troponin T cardiac biomarkers measured with an assay of blood taken via venous blood draw, echocardiography-derived left ventricular twist. The exploratory outcome measure will be treatment symptoms as reported by the Rotterdam Symptom Checklist. Cardiac outcome measures will be performed at the following time points: 1) Post diagnosis and prior to the first cycle of anthracyclines; 2) 24-48 hours after the first cycle; 3) at least one week after the last cycle of anthracyclines, but before subsequent chemotherapy treatments. The Rotterdam will be performed at baseline and within the last few days of each treatment cycle.

Baseline characteristics of the two groups will be compared with independent t-tests. Descriptive statistics and frequencies will be calculated for all continuous and categorical variables. The acute effect will be determined by the difference between time points 1) and 2). The chronic effect will be determined by the difference between time points 1) and 3). For each analysis, a linear mixed model with time as a fixed and repeated effect, group as a fixed effect, and a time by condition (2 x 2) interaction will be used. If the interaction effect is not statistically significant, the main effects of time and condition will be explored. An alpha of 0.05 will be used for all analyses.

Acute Exercise Cardioprotection From Doxorubicin

The Effects of Exercise Before Doxorubicin Chemotherapy on Cardiac Function

As assessed by standardized scores of physical and psychological distress by the Rotterdam Symptom Checklist

Assessed with 2D speckle tracking echocardiography

British Columbia Cancer Agency

University of British Columbia

Dr. Kristin Campbell

Serious adverse events related to the study intervention.

an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise

Exercise

Usual Care

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Canada

Region of Enrollment

Body weight

Hemoglobin

6-month MVPA

LVEF

Cardiac output

Resting HR

Systemic vascular resistance

E/A ratio

Mean arterial pressure

Body mass index

One participant in the usual care group did not complete baseline assessment. One participant in usual care group completed baseline assessment before protocol violation (did not receive any of study drug) and was excluded. One participant in the exercise group withdrew immediately after the baseline assessment and did not start the intervention.

Dr. Amy Kirkham, Postdoctoral Research Fellow

Baseline

24-48 h post first doxorubicin

7-14 days post last doxorubicin

Global Longitudinal Strain

NT-proBNP

Cardiac Troponin T

LV Twist

Patient-reported Symptoms

an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post

exercise: An acute bout of exercise performed 24 hours prior to every anthracycline infusion.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Cardiotoxic Effects of Bortezomib	NCT02026505	Multiple Myelom... Heart Failure, ... Cardiotoxins	Bortezomib	18 Years - 70 Years	Oregon Health and Science University
Acute Exercise Cardioprotection From Doxorubicin	NCT02006979	Breast Cancer	exercise	18 Years -	University of British Columbia

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