Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Chemotherapy for Primary Breast Cance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716893
• Other study ID #: 22-364
• Status: Recruiting
• Phase: Phase 2
• Start date: January 30, 2023
• Est. completion date: January 30, 2028

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jessica Scott, PhD
• Phone: 646-888-8093
• Email: scottj1[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 30, 2028
• Est. primary completion date: January 30, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms

Intervention

Behavioral:
• Adaptive Aerobic Training/AT Dosing
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 ?<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF ?>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx.
• Standard (fixed) Aerobic Training/AT dosing
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 ?<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF ?>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited protocol activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	32 weeks from baseline

External Links

•   Memorial Sloan Kettering Cancer Center