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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited protocol activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited protocol activities)
RECRUITING
Rockville Centre
Contact Information
Primary
Jessica Scott, PhD
scottj1@mskcc.org
646-888-8093
Backup
Anthony Yu, MD
yua3@mskcc.org
212-639-5154
Time Frame
Start Date: 2023-01-30
Estimated Completion Date: 2028-01-30
Participants
Target number of participants: 140
Treatments
Experimental: Adaptive Aerobic Training/AT Dosing
Participants with newly diagnosed primary breast cancer initiating chemotherapy.
Active_comparator: Standard (fixed) Aerobic Training/AT dosing
Participants with newly diagnosed primary breast cancer initiating chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov