Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Hormone Receptor Positive Metastatic Breast Cancer

Treatments: Other: Exercise Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03988595

19-113

Details and patient eligibility

About

This study will test any good and bad effects of aerobic exercise performed while you are receiving the usual first-line treatment for metastatic breast cancer. The researchers think that exercise helps delay the development of resistance to hormone therapy while slowing the growth of tumors.

Enrollment: 54 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative metastatic breast cancer (MBC)
• Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression
• Receiving first line endocrine-based therapy (tamoxifen, aromatase inhibitor, or fulvestrant; concurrent molecular therapy also allowed)
• Sedentary (i.e., <60 minutes / week of exercise)
• Age >18 years
• BMI ≥ 18.5
• Cleared for exercise participation as per screening clearance via PAR-Q+
• Cleared for study participation as per screening consultation with an MSK Exercise Physiologist
• Willingness to comply with all study-related procedures
• Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled

Exclusion criteria

• Life expectancy <6 months
• Enrollment onto any other therapeutic investigational study
• Mental impairment leading to inability to cooperate
• Concurrent participation in weight loss or other exercise programs

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 5 patient groups

aerobic training 90 mins/wk

Experimental group

Description:

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Treatment:

Other: Exercise Treatment

aerobic training 150 mins/wk

Experimental group

Description:

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Treatment:

Other: Exercise Treatment

aerobic training 225 mins/wk

Experimental group

Description:

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Treatment:

Other: Exercise Treatment

aerobic training 300 mins/week

Experimental group

Description:

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Treatment:

Other: Exercise Treatment

aerobic training 375 mins/week

Experimental group

Description:

Exercise sessions will consist of individualized, walking delivered following a non-linear(i.e., exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Treatment:

Other: Exercise Treatment