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Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

Primary Purpose

Breast Cancer, Breast Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adaptive Aerobic Training/AT Dosing
Standard (fixed) Aerobic Training/AT dosing
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Breast carcinoma, Primary breast cancer, Aerobic Training, 22-364, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Aged ≥18 years Female Diagnosed with primary breast cancer as defined by one of the following: Histological confirmation As per standard of care imaging Scheduled to receive neoadjuvant/adjuvant chemotherapy Performing ≤90 minutes of moderate- and/or strenuous-intensity exercise per week, as evaluated by self-report Willingness to comply with all study-related procedures 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. Exclusion Criteria: Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes Receiving treatment for any other diagnosis of invasive cancer Distant metastatic malignancy of any kind Mental impairment leading to inability to cooperate Any of the following contraindications to cardiopulmonary exercise testing: i. Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Respiratory failure; xv. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) xvi. Room air desaturation at rest ≤ 85% Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited protocol activities)Recruiting
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited protocol activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive Aerobic Training/AT Dosing

Standard (fixed) Aerobic Training/AT dosing

Arm Description

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Outcomes

Primary Outcome Measures

Cardiorespiratory fitness (CRF) response rate
The primary endpoint will be CRF response rate as assessed by the proportion of patients with a peak oxygen consumption (VO2peak; ml O2 .kg-1.min-1 ) change from baseline (T0) to T2 (~32 weeks) of ≥3.50 ml O2 .kg-1.min-1 . A CRF change ≥3.50 ml O2 .kg-1.min-1 will be considered a response; a change <3.50 ml O2 .kg-1.min-1 will be considered a non-response.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2023
Last Updated
February 15, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05716893
Brief Title
Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer
Official Title
Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Chemotherapy for Primary Breast Cance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
January 30, 2028 (Anticipated)
Study Completion Date
January 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this study, investigators will compare standard Aerobic Training/AT with adaptive Aerobic Training/AT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise. Investigators will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Carcinoma
Keywords
Breast cancer, Breast carcinoma, Primary breast cancer, Aerobic Training, 22-364, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Aerobic Training/AT Dosing
Arm Type
Experimental
Arm Description
Participants with newly diagnosed primary breast cancer initiating chemotherapy.
Arm Title
Standard (fixed) Aerobic Training/AT dosing
Arm Type
Active Comparator
Arm Description
Participants with newly diagnosed primary breast cancer initiating chemotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Aerobic Training/AT Dosing
Intervention Description
o In Phase A (~32 weeks), AT will consist of supervised walking delivered up to 7 days per week using an adaptive dosing schedule that starts at 90 min/wk and is escalated 30 min/wk every 2 weeks to a maximal dose of 300 mins/wk. In Phase B (~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF Δ>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx.
Intervention Type
Behavioral
Intervention Name(s)
Standard (fixed) Aerobic Training/AT dosing
Intervention Description
In Phase A (~32 weeks), AT will consist of supervised walking delivered up to 7 days per week to achieve a cumulative total duration of: 90 min/wk (standard fixed dosing). In Phase B (~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF Δ>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx.
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness (CRF) response rate
Description
The primary endpoint will be CRF response rate as assessed by the proportion of patients with a peak oxygen consumption (VO2peak; ml O2 .kg-1.min-1 ) change from baseline (T0) to T2 (~32 weeks) of ≥3.50 ml O2 .kg-1.min-1 . A CRF change ≥3.50 ml O2 .kg-1.min-1 will be considered a response; a change <3.50 ml O2 .kg-1.min-1 will be considered a non-response.
Time Frame
32 weeks from baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥18 years Female Diagnosed with primary breast cancer as defined by one of the following: Histological confirmation As per standard of care imaging Scheduled to receive neoadjuvant/adjuvant chemotherapy Performing ≤90 minutes of moderate- and/or strenuous-intensity exercise per week, as evaluated by self-report Willingness to comply with all study-related procedures 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. Exclusion Criteria: Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes Receiving treatment for any other diagnosis of invasive cancer Distant metastatic malignancy of any kind Mental impairment leading to inability to cooperate Any of the following contraindications to cardiopulmonary exercise testing: i. Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Respiratory failure; xv. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) xvi. Room air desaturation at rest ≤ 85% Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Scott, PhD
Phone
646-888-8093
Email
scottj1@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Jones, PhD
Phone
646-888-8103
Email
jonesl3@mskcc.org
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 Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Scott, PhD
Phone
646-888-8093
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Scott, PhD
Phone
646-888-8093
Facility Name
Memorial Sloan Kettering Bergen (Limited protocol activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Scott, PhD
Phone
646-888-8093
Facility Name
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Scott, PhD
Phone
646-888-8093
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Scott, PhD
Phone
646-888-8093
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Scott, PhD
Phone
646-888-8093
Facility Name
Memorial Sloan Kettering Nassau (Limited protocol activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Scott, PhD
Phone
646-888-8093

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

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