## Protocol Section
### Identification Module
**NCT ID:** NCT02006979

**Brief Title:** Acute Exercise Cardioprotection From Doxorubicin

**Official Title:** The Effects of Exercise Before Doxorubicin Chemotherapy on Cardiac Function

#### Organization Study ID Info
**ID:** H13-03090
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2016-05-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-10-25

**Type:** ACTUAL

**Last Update Submit Date:** 2019-10-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-05-25

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-10-25

**Type:** ACTUAL

**Results First Submit Date:** 2017-11-08

**Results First Submit QC Date:** 2019-10-23

#### Start Date
**Date:** 2016-01-15

**Type:** ACTUAL

**Status Verified Date:** 2019-10

#### Study First Post Date
**Date:** 2013-12-10
**Type:** ESTIMATED
**Study First Submit Date:** 2013-12-05
**Study First Submit QC Date:** 2013-12-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** British Columbia Cancer Agency

#### Lead Sponsor

**Class:** OTHER

**Name:** University of British Columbia

#### Responsible Party

**Investigator Affiliation:** University of British Columbia

**Investigator Full Name:** Kristin Campbell

**Investigator Title:** Dr. Kristin Campbell

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** 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.

### Conditions Module

**Conditions:**

- Breast Cancer

**Keywords:**

- cardiotoxicity

- Chemotherapy, Adjuvant

- Breast Neoplasms

- Exercise

- Cardiotoxins

- Echocardiography

- Speckle tracking

- Biological Markers

- Electrocardiography

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 27

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: exercise

**Label:** Exercise

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** No exercise

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exercise

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

**Name:** exercise

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

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

**Measure:** Patient-reported Symptoms

**Time Frame:** <1 week before the first doxorubicin, <3 days before the 2nd, 3rd, and 4th doxorubicin, 7-14 days after completion of the last doxorubicin cycle

#### Primary Outcomes

**Description:** Assessed with 2D speckle tracking echocardiography

**Measure:** Global Longitudinal Strain

**Time Frame:** 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle

#### Secondary Outcomes

**Description:** biomarker of cardiac injury

**Measure:** NT-proBNP

**Time Frame:** 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle

**Description:** biomarker of cardiac injury

**Measure:** Cardiac Troponin T

**Time Frame:** 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle

**Description:** Assessed with 2D speckle tracking echocardiography

**Measure:** LV Twist

**Time Frame:** 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* newly diagnosed with stage I-IIIA breast cancer
* scheduled to receive neoadjuvant or adjuvant doxorubicin chemotherapy in cycles of 2-3 weeks long
* receive their oncologist's approval to exercise
* be able to complete first time point of data collection prior to first chemotherapy cycle
* be able to understand and provide written informed consent in English

Exclusion Criteria:

* concurrent participation in a structured exercise program or study
* have orthopedic limitations to exercise
* pre-existing cardiovascular disease
* uncontrolled hypertension (blood pressure ≥ 140/90 mmHg)
* uncontrolled diabetes
* respiratory disease
* current smoking status

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Vancouver

**Country:** Canada

**Facility:** University of British Columbia Breast Cancer Research Exercise Gym

**State:** British Columbia

**Zip:** V5Z 4C2

#### Overall Officials

**Official 1:**

**Affiliation:** University of British Columbia

**Name:** Kristin L Campbell, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M30670

- Name: Cardiotoxicity

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7492

- Name: Doxorubicin

- Relevance: LOW

- As Found: Unknown

- ID: M227339

- Name: Liposomal doxorubicin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Serious adverse events related to the study intervention.

#### Event Groups

**Group ID:** EG000

**Title:** Exercise

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

**ID:** EG000

**Other Num at Risk:** 13

**Serious Number At Risk:** 13

**Title:** Exercise

**Group ID:** EG001

**Title:** Usual Care

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

**ID:** EG001

**Other Num at Risk:** 11

**Serious Number At Risk:** 11

**Title:** Usual Care

**Frequency Threshold:** 0

**Time Frame:** During intervention period which lasted from shortly prior to the first doxorubicin treatment to 7-14 days after the last doxorubicin treatment.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 13

**Group ID:** BG001

**Value:** 11

**Group ID:** BG002

**Value:** 24

**Units:** Participants

### Group

**ID:** BG000

**Title:** Exercise

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

### Group

**ID:** BG001

**Title:** Usual Care

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

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9

**Value:** 50

#### Measurement

**Group ID:** BG001

**Spread:** 10

**Value:** 50

#### Measurement

**Group ID:** BG002

**Spread:** 9

**Value:** 50

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 24

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 5

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 24

**Class Title:** Canada

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.7

**Value:** 69.7

#### Measurement

**Group ID:** BG001

**Spread:** 12.7

**Value:** 72.2

#### Measurement

**Group ID:** BG002

**Spread:** 12.7

**Value:** 71.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.0

**Value:** 13.0

#### Measurement

**Group ID:** BG001

**Spread:** 1.1

**Value:** 12.7

#### Measurement

**Group ID:** BG002

**Spread:** 1.0

**Value:** 12.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 0

**Upper Limit:** 701

**Value:** 214

#### Measurement

**Group ID:** BG001

**Lower Limit:** 0

**Upper Limit:** 619

**Value:** 124

#### Measurement

**Group ID:** BG002

**Lower Limit:** 0

**Upper Limit:** 701

**Value:** 165

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4

**Value:** 57

#### Measurement

**Group ID:** BG001

**Spread:** 3

**Value:** 58

#### Measurement

**Group ID:** BG002

**Spread:** 3

**Value:** 58

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.6

**Value:** 3.2

#### Measurement

**Group ID:** BG001

**Spread:** 0.5

**Value:** 3.0

#### Measurement

**Group ID:** BG002

**Spread:** 0.5

**Value:** 3.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11

**Value:** 69

#### Measurement

**Group ID:** BG001

**Spread:** 12

**Value:** 69

#### Measurement

**Group ID:** BG002

**Spread:** 11

**Value:** 69

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 445

**Value:** 1933

#### Measurement

**Group ID:** BG001

**Spread:** 514

**Value:** 2074

#### Measurement

**Group ID:** BG002

**Spread:** 472

**Value:** 1998

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.37

**Value:** 1.20

#### Measurement

**Group ID:** BG001

**Spread:** 0.32

**Value:** 1.27

#### Measurement

**Group ID:** BG002

**Spread:** 0.34

**Value:** 1.23

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10

**Value:** 75

#### Measurement

**Group ID:** BG001

**Spread:** 11

**Value:** 76

#### Measurement

**Group ID:** BG002

**Spread:** 11

**Value:** 76

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4.8

**Value:** 25.0

#### Measurement

**Group ID:** BG001

**Spread:** 5.1

**Value:** 26.7

#### Measurement

**Group ID:** BG002

**Spread:** 4.9

**Value:** 25.8

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body weight
**Unit of Measure:** kg
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Hemoglobin
**Unit of Measure:** g/dL
### Measure 7
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** 6-month MVPA
**Unit of Measure:** average weekly minutes
### Measure 8
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** LVEF
**Unit of Measure:** %
### Measure 9
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Cardiac output
**Unit of Measure:** L/min
### Measure 10
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Resting HR
**Unit of Measure:** beats per minute
### Measure 11
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Systemic vascular resistance
**Unit of Measure:** dynes·sec·cm-5
### Measure 12
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** E/A ratio
**Unit of Measure:** no units
### Measure 13
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Mean arterial pressure
**Unit of Measure:** mmHg
### Measure 14
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body mass index
**Unit of Measure:** kg/m2
**Population Description:** 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.
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** amy.kirkham@ualberta.ca
**Organization:** University of Alberta
**Phone:** 7804926874
**Title:** Dr. Amy Kirkham, Postdoctoral Research Fellow
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** 19.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -19.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.8
- **Upper Limit:** 
- **Value:** 21.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** -21.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.4
- **Upper Limit:** 
- **Value:** -18.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** -20.3
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 30
- **Upper Limit:** 
- **Value:** 52
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 35
- **Upper Limit:** 
- **Value:** 59
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 77
- **Upper Limit:** 
- **Value:** 214
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 151
- **Upper Limit:** 
- **Value:** 323
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 78
- **Upper Limit:** 
- **Value:** 106
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 39
- **Upper Limit:** 
- **Value:** 77
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** 1.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.3
- **Upper Limit:** 
- **Value:** 1.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.2
- **Upper Limit:** 
- **Value:** 2.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.6
- **Upper Limit:** 
- **Value:** 1.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.2
- **Upper Limit:** 
- **Value:** 13.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.3
- **Upper Limit:** 
- **Value:** 11.6
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.6
- **Upper Limit:** 
- **Value:** 16.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.9
- **Upper Limit:** 
- **Value:** 16.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.5
- **Upper Limit:** 
- **Value:** 20.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.8
- **Upper Limit:** 
- **Value:** 22.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.5
- **Upper Limit:** 
- **Value:** 15.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.6
- **Upper Limit:** 
- **Value:** 15.6
**Title:** 
#### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Assessed with 2D speckle tracking echocardiography
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle
**Title:** Global Longitudinal Strain
**Type:** PRIMARY
**Unit of Measure:** % deformation
##### Group
**Description:** an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
**ID:** OG000
**Title:** Exercise
##### Group
**Description:** no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
**ID:** OG001
**Title:** Usual Care
#### Outcome Measure 2
**Description:** biomarker of cardiac injury
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle
**Title:** NT-proBNP
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
**ID:** OG000
**Title:** Exercise
##### Group
**Description:** no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
**ID:** OG001
**Title:** Usual Care
#### Outcome Measure 3
**Description:** biomarker of cardiac injury
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle
**Title:** Cardiac Troponin T
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
**ID:** OG000
**Title:** Exercise
##### Group
**Description:** no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
**ID:** OG001
**Title:** Usual Care
#### Outcome Measure 4
**Description:** Assessed with 2D speckle tracking echocardiography
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle
**Title:** LV Twist
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
**ID:** OG000
**Title:** Exercise
##### Group
**Description:** no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
**ID:** OG001
**Title:** Usual Care
#### Outcome Measure 5
**Description:** As assessed by standardized scores of physical and psychological distress by the Rotterdam Symptom Checklist
**Reporting Status:** NOT_POSTED
**Time Frame:** <1 week before the first doxorubicin, <3 days before the 2nd, 3rd, and 4th doxorubicin, 7-14 days after completion of the last doxorubicin cycle
**Title:** Patient-reported Symptoms
**Type:** OTHER_PRE_SPECIFIED
### Participant Flow Module
#### Group
**Description:** 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.
**ID:** FG000
**Title:** Exercise
#### Group
**Description:** no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
**ID:** FG001
**Title:** Usual Care
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 11
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Has Results:** True