A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes. The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• Aged 21-80 years

• Female

• Surgically resected early stage (I-III) primary breast cancer

• Post-menopausal, defined as one of the following:

‣ Age ≥ 45 with no menses for at least 2 years

⁃ Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist

⁃ Estradiol level of ≤30 pg/mL

• An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as:

‣ Surgery plus radiation

⁃ Surgery plus chemotherapy

⁃ Surgery plus trastuzumab

• Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)\].

∙ Note: Normative values are available up to 80 years of age)

• Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, 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 comply with all study-related procedures.

Locations
United States
Connecticut
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)
RECRUITING
Hartford
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
Jessica Scott, PhD
scottj1@mskcc.org
646-888-8103
Backup
Lee Jones, PhD
646-888-8103
Time Frame
Start Date: 2020-10-08
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 152
Treatments
Experimental: (A) breast cancer after completion of chemo
300 min/wk for 16 weeks, followed by 16 weeks of usual care.
Experimental: (B) breast cancer after completion of chemo
150 min/wk for 32 weeks.
Experimental: (C) breast cancer after completion of chemo
300 min/wk for 32 weeks.
Active_comparator: (D) breast cancer after completion of chemo
150 min/wk for 16 weeks, followed by 16 weeks of usual care.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov