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Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

Primary Purpose

Breast Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aerobic Training

Educational Information

Supervised Home Based Training

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Exercise, Chemotherapy, 15-178

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Aged 21-80 years
Female
MSK histologically confirmed early-stage operable breast cancer
Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
ECOG status of 0 or 1
Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week
If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
a. Women < 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy.
Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:
- Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
- A respiratory exchange ratio ≥ 1.10;
- Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
- Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
Willingness to be randomized to one of the study arms

Exclusion Criteria:

Presence of any other concurrent, actively treated malignancy
History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
Presence of metastatic disease
Any of the following contraindications to cardiopulmonary exercise testing:
Acute myocardial infarction within 3-5 days of any planned study procedures)
Unstable angina
Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
Recurrent syncope
Active endocarditis
Acute myocarditis or pericarditis
Symptomatic severe aortic stenosis
Uncontrolled heart failure
Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures;
Thrombosis of lower extremities
Suspected dissecting aneurysm
Uncontrolled asthma
Pulmonary edema
Respiratory failure
Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) or
Room air desaturation at rest ≤ 85%
Mental impairment leading to inability to cooperate.
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Aerobic Training During Chemotherapy

Aerobic Training After Chemotherapy

Continuous Aerobic Training

General Physical Activity Group

Arm Description

The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training an intensity of at 55% to 100% of the individually determined exercise capacity VO2peak), concurrent with chemotherapy. VO2peak will be determined by the CPET performed at baseline. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training at an intensity 55% to 100% of the individually determined exercise capacity (VO2peak), after the completion of chemotherapy. VO2peak will be determined by the CPET performed at midpoint, or pre-surgery for neoadjuvant patients. For patients receiving adjuvant therapy, (except those who have additional surgery after chemotherapy), the aerobic training intervention must begin within 2 weeks of the patient's midpoint CPET. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, the aerobic training intervention will begin within approximately 6 weeks of surgery, per the discretion of the treating physician. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

The ultimate goal is for participants to complete 3 exercise sessions week of non-linear aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), during and after chemotherapy. For patients receiving adjuvant therapy (except those who have additional surgery after chemotherapy), VO2peak will be determined by the CPETs performed at baseline and midpoint. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, VO2peak will be determined by the CPETs or at baseline, pre- surgery, and post-surgery. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.

Patients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, consultation with a staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients can be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients may also be provided with an exercise log to record type, duration, and average heart rate during sessions. The exercise log is provided as a guidance tool and may be, although is not required to be, returned to study staff. Staff exercise physiologists will contact patients to check progress, and answer questions.

Outcomes

Primary Outcome Measures

Change in VO2 peak (functional capacity)

To determine the optimal timing of aerobic activity, relative to an attention-control group, on exercise capacity in a breast cancer setting. This will be evaluated using an electronic motorized treadmill test with 12-lead ECG monitoring (Mac® 5000, GE Healthcare) performed by certified exercise physiologists.

Secondary Outcome Measures

Quality of Life measured by questionnaire during and after Chemotherapy

Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

Sleeping patterns as measured by questionnaire during and after Chemotherapy

Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

Depression scale during and after Chemotherapy

Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

Physical activity recall during and after Chemotherapy

Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

Skeletal Muscle Function

To examine the physiological mediators of the exercise training - exercise capacity relationship (e.g., skeletal muscle function as assessed by a muscle biopsy)performed.

Full Information

NCT ID

NCT01943695

First Posted

July 31, 2013

Last Updated

March 3, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01943695

Brief Title

Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

Official Title

Optimal Timing Trial: Randomized Trial of Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 2013 (undefined)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer. The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Exercise, Chemotherapy, 15-178

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerobic Training During Chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

Aerobic Training After Chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

Continuous Aerobic Training

Arm Type

Experimental

Arm Description

Arm Title

General Physical Activity Group

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Training

Other Intervention Name(s)

exercise, breast cancer, therapy.

Intervention Type

Behavioral

Intervention Name(s)

Educational Information

Intervention Description

Subjects will be given material regarding cancer and it's impact.

Intervention Type

Behavioral

Intervention Name(s)

Supervised Home Based Training

Intervention Description

Patients that elect supervised home based training platform or plan to complete unsupervised training sessions will receive a study kit which includes a heart rate monitor, blood pressure cuff, treadmill and tablet to complete aerobic training requirements. The study kit will be given to the patient upon completion of their baseline testing. The treadmill will be shipped to the patient's home and coordinated by the Ex Onc group. The treadmills are MSK owned equipment that will be deployed to the patient's homes via the vendor TechnoGym. A member of Ex Onc will provide an orientation session for the patient to set up all study kit items. If there is a delay in the patient receiving the treadmill , or any other unforeseen circumstance, patients may be assigned a temporary unsupervised training program until the treadmill is delivered.

Primary Outcome Measure Information:

Title

Change in VO2 peak (functional capacity)

Description

Time Frame

during chemotherapy 3-6 months depending on treatment recommendations

Secondary Outcome Measure Information:

Title

Quality of Life measured by questionnaire during and after Chemotherapy

Description

Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

Time Frame

at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

Title

Sleeping patterns as measured by questionnaire during and after Chemotherapy

Description

Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

Time Frame

at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

Title

Depression scale during and after Chemotherapy

Description

Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

Time Frame

at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

Title

Physical activity recall during and after Chemotherapy

Description

Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

Time Frame

at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

Title

Skeletal Muscle Function

Description

To examine the physiological mediators of the exercise training - exercise capacity relationship (e.g., skeletal muscle function as assessed by a muscle biopsy)performed.

Time Frame

at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 21-80 years Female MSK histologically confirmed early-stage operable breast cancer Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting ECOG status of 0 or 1 Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study. a. Women < 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy. Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator. Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: Achieving a plateau in oxygen consumption, concurrent with an increase in power output; A respiratory exchange ratio ≥ 1.10; Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]); Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. Willingness to be randomized to one of the study arms Exclusion Criteria: Presence of any other concurrent, actively treated malignancy History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer) Presence of metastatic disease Any of the following contraindications to cardiopulmonary exercise testing: Acute myocardial infarction within 3-5 days of any planned study procedures) Unstable angina Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; Recurrent syncope Active endocarditis Acute myocarditis or pericarditis Symptomatic severe aortic stenosis Uncontrolled heart failure Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; Thrombosis of lower extremities Suspected dissecting aneurysm Uncontrolled asthma Pulmonary edema Respiratory failure Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) or Room air desaturation at rest ≤ 85% Mental impairment leading to inability to cooperate. Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica Scott, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mskcc.org/

Description

Memorial Sloan Kettering Cancer Center

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Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

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