RECRUITING

Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

Conditions

Breast Cancer Breast Carcinoma Primary breast cancer Aerobic Training 22-364 Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-30

Study Completion:2028-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05716893

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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: * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Inclusion Criteria

Exclusion 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.

* 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:
* Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation

Contacts and Locations

Study Contact

Jessica Scott, PhD

CONTACT

646-888-8093

scottj1@mskcc.org

Lee Jones, PhD

CONTACT

646-888-8103

jonesl3@mskcc.org

Principal Investigator

Jessica Scott, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Jessica Scott, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-30

Study Completion Date2028-01-30

Study Record Updates

Study Start Date2023-01-30

Study Completion Date2028-01-30

Terms related to this study

Keywords Provided by Researchers

Breast cancer
Breast carcinoma
Primary breast cancer
Aerobic Training
22-364
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Breast Cancer
Breast Carcinoma