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Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer
Trial Status: active
This phase II trial compares adaptive aerobic training (AT) to standard AT for improving cardiorespiratory (lung, heart, blood vessel, and muscle function) fitness in patients receiving chemotherapy for breast cancer. Patients receiving anti-cancer therapy such as chemotherapy often experience negative effects on their cardiorespiratory fitness (CRF). Research has found that AT is an effective way to improve CRF in people while they are treated for breast cancer. However, researchers have not yet found the level(s) of exercise that will be the most helpful for people undergoing cancer treatment. Adaptive AT adjusts the level of exercise depending on participants’ response to the exercise. Standard AT is a fixed (unchanging) amount of walking each week. This trial compares adaptive AT to standard AT for improving CRF in patients receiving chemotherapy for breast cancer.
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 cardiopulmonary exercise test (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 beats per minute [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 principal investigator (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:
* 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)
* 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
Additional locations may be listed on ClinicalTrials.gov for NCT05716893.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Jessica Scott
Phone: 646-888-8103
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Jessica Scott
Phone: 646-888-8103
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Jessica Scott
Phone: 646-888-8103
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Jessica Scott
Phone: 646-888-8103
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Jessica Scott
Phone: 646-888-8103
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Jessica Scott
Phone: 646-888-8103
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Jessica Scott
Phone: 646-888-8103
PRIMARY OBJECTIVE:
I. To compare the effects of adaptive versus standard AT dosing on CRF response rate as assessed by the proportion of patients with a CRF change from baseline (T0) to after chemotherapy (T2) of >= 3.50 ml O2 x kg^-1 x min^-1.
SECONDARY OBJECTIVES:
I. To compare CRF change between patients receiving adaptive versus standard AT dosing (as a continuous variable delta T0 to T2).
II. To compare change in patient-reported outcomes (delta T0 to T2) between patients receiving adaptive versus standard AT dosing.
III. To compare AT safety and tolerability from T0 to T2 between patients receiving adaptive versus standard AT dosing.
EXPLORATORY OBJECTIVES:
I. Estimate the CRF response rate at the end of phase B (delta T0 to T3). (Separately for the following 4 groups: non-responders to adaptive AT in phase A; non-responders to standard AT in phase A; responders to adaptive AT in phase A; responders to standard AT in phase A)
II. Estimate CRF change (as a continuous variable) at the end of phase B (delta T0 to T3). (Separately for the following 4 groups: non-responders to adaptive AT in phase A; non-responders to standard AT in phase A; responders to adaptive AT in phase A; responders to standard AT in phase A)
III. Estimate changes in patient reported outcomes at the end of phase B (delta T0 to T3). (Separately for the following 4 groups: non-responders to adaptive AT in phase A; non-responders to standard AT in phase A; responders to adaptive AT in phase A; responders to standard AT in phase A)
IV. Estimate the difference in CRF response rates between phase A and phase B ([delta T0 to T3] relative to [delta T0 to T2]). (Separately for the following 4 groups: non-responders to adaptive AT in phase A; non-responders to standard AT in phase A; responders to adaptive AT in phase A; responders to standard AT in phase A)
V. Estimate the difference in the change in CRF as a continuous variable between phase A and phase B ([delta T0 to T3] relative to [delta T0 to T2]). (Separately for the following 4 groups: non-responders to adaptive AT in phase A; non-responders to standard AT in phase A; responders to adaptive AT in phase A; responders to standard AT in phase A)
VI. Estimate the differences in the changes in patient-reported outcomes between phase A and phase B ([delta T0 to T3] relative to [delta T0 to T2]). (Separately for the following 4 groups: non-responders to adaptive AT in phase A; non-responders to standard AT in phase A; responders to adaptive AT in phase A; responders to standard AT in phase A)
VII. To explore effects on AT safety and tolerability from T2 to T3.
VIII. To explore effects of AT on chemotherapy tolerability (T0 to T1).
IX. To explore AT pharmacodynamics as evaluated by changes in physiological (e.g., body weight, blood pressure, heart rate, fitness score, glucose).
X. To collect and bank blood for future correlative studies.
OUTLINE:
PHASE A: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive supervised adaptive dosing aerobic training intervention for 32 weeks on study. Patients also undergo collection of blood samples throughout the trial.
ARM B: Patients receive supervised standard dosing aerobic training intervention for 32 weeks on study. Patients also undergo collection of blood samples throughout the trial.
PHASE B: Patients determined to be non-responders are assigned to arm C and patients determined to be responders are assigned to arm D.
ARM C: Non-responder patients receive supervised adaptive dosing aerobic training intervention for 20 weeks on study. Patients also undergo collection of blood samples throughout the trial.
ARM D: Responder patients receive unsupervised usual care aerobic training for 20 weeks on study. Patients also undergo collection of blood samples throughout the trial.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
