Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

Breast Cancer Clinical Trial

Official title:

Optimal Timing Trial: Randomized Trial of Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01943695
• Other study ID #: 15-178
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer. The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged 21-80 years
• Female
• MSK histologically confirmed early-stage operable breast cancer
• Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
• ECOG status of 0 or 1
• Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week
• If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study. a. Women < 50 years old must have a negative pregnancy test (urine HCG or serum ßHCG) within 2 weeks of beginning chemotherapy.
• Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
• 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.
• Willingness to be randomized to one of the study arms

Exclusion Criteria:

• Presence of any other concurrent, actively treated malignancy
• History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
• Presence of metastatic disease
• 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) or
• Room air desaturation at rest = 85%
• Mental impairment leading to inability to cooperate.
• Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Aerobic Training

• Educational Information
Subjects will be given material regarding cancer and it's impact.
• Supervised Home Based Training
Patients that elect supervised home based training platform or plan to complete unsupervised training sessions will receive a study kit which includes a heart rate monitor, blood pressure cuff, treadmill and tablet to complete aerobic training requirements. The study kit will be given to the patient upon completion of their baseline testing. The treadmill will be shipped to the patient's home and coordinated by the Ex Onc group. The treadmills are MSK owned equipment that will be deployed to the patient's homes via the vendor TechnoGym. A member of Ex Onc will provide an orientation session for the patient to set up all study kit items. If there is a delay in the patient receiving the treadmill , or any other unforeseen circumstance, patients may be assigned a temporary unsupervised training program until the treadmill is delivered.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	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	Change in VO2 peak (functional capacity)	To determine the optimal timing of aerobic activity, relative to an attention-control group, on exercise capacity in a breast cancer setting. This will be evaluated using an electronic motorized treadmill test with 12-lead ECG monitoring (Mac® 5000, GE Healthcare) performed by certified exercise physiologists.	during chemotherapy 3-6 months depending on treatment recommendations
Secondary	Quality of Life measured by questionnaire during and after Chemotherapy	Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.	at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Secondary	Sleeping patterns as measured by questionnaire during and after Chemotherapy	Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.	at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Secondary	Depression scale during and after Chemotherapy	Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.	at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Secondary	Physical activity recall during and after Chemotherapy	Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.	at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Secondary	Skeletal Muscle Function	To examine the physiological mediators of the exercise training - exercise capacity relationship (e.g., skeletal muscle function as assessed by a muscle biopsy)performed.	at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

External Links

•   Memorial Sloan Kettering Cancer Center