Trial Title:
Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer
NCT ID:
NCT05716893
Condition:
Breast Cancer
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Breast carcinoma
Primary breast cancer
Aerobic Training
22-364
Memorial Sloan Kettering Cancer Center
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Adaptive Aerobic Training/AT Dosing
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.
Arm group label:
Adaptive Aerobic Training/AT Dosing
Intervention type:
Behavioral
Intervention name:
Standard (fixed) Aerobic Training/AT dosing
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.
Arm group label:
Standard (fixed) Aerobic Training/AT dosing
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.
Criteria for 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:
1. Achieving a plateau in oxygen consumption, concurrent with an increase in power
output;
2. A respiratory exchange ratio ≥ 1.10;
3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of
age-predicted HRmax [HRmax = 220-Age[years]);
4. 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8093
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8093
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited protocol activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8093
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8093
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8093
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8093
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited protocol activities)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8093
Start date:
January 30, 2023
Completion date:
January 30, 2028
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05716893
http://www.mskcc.org
