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Exercise Treatment for Breast Cancer
Phase 1
Recruiting
Led By Neil Iyengar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative metastatic breast cancer (MBC)
Age >18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial will test the benefits and risks of aerobic exercise for patients with metastatic breast cancer who are receiving hormone therapy. Researchers think that exercise may help delay the development of resistance to hormone therapy and slow the growth of tumors.
Who is the study for?
This trial is for postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer who are sedentary and starting first-line endocrine therapy. They must be cleared for exercise, willing to follow study procedures, have a BMI of at least 18.5, and can't be in other exercise or weight loss programs or have a life expectancy under six months.Check my eligibility
What is being tested?
The study is examining the effects of aerobic exercise alongside standard first-line treatment for metastatic breast cancer. The goal is to see if exercise can help delay resistance to hormone therapy and slow tumor growth.See study design
What are the potential side effects?
While specific side effects aren't listed for the exercise intervention, typical risks might include muscle soreness, fatigue, joint pain or injury from physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is HR-positive and HER2-negative.
Select...
I am older than 18 years.
Select...
I am postmenopausal due to no periods for 2 years, surgery, or treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
maximum feasible dose (MFD)
Trial Design
5Treatment groups
Experimental Treatment
Group I: aerobic training 90 mins/wkExperimental Treatment1 Intervention
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.
Group II: aerobic training 375 mins/weekExperimental Treatment1 Intervention
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.
Group III: aerobic training 300 mins/weekExperimental Treatment1 Intervention
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.
Group IV: aerobic training 225 mins/wkExperimental Treatment1 Intervention
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.
Group V: aerobic training 150 mins/wkExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,836 Total Patients Enrolled
203 Trials studying Breast Cancer
81,103 Patients Enrolled for Breast Cancer
Neil Iyengar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
390 Total Patients Enrolled
4 Trials studying Breast Cancer
315 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is HR-positive and HER2-negative.You do not exercise regularly, meaning you do less than 60 minutes of exercise per week.You are currently taking part in a weight loss or exercise program.You have trouble understanding or following instructions.My brain lesions have been treated and stable for 2 months or more.You are not expected to live for more than 6 months.You have a body mass index (BMI) of 18.5 or higher.I am older than 18 years.I am postmenopausal due to no periods for 2 years, surgery, or treatment.I am currently on my first hormone therapy for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: aerobic training 225 mins/wk
- Group 2: aerobic training 375 mins/week
- Group 3: aerobic training 90 mins/wk
- Group 4: aerobic training 150 mins/wk
- Group 5: aerobic training 300 mins/week
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How well documented are the safety benefits of Exercise Treatment?
"The safety of Exercise Treatment, which is in Phase 1 trials and has limited data backing up its efficacy, was assessed as a score of 1."
Answered by AI
In what quantity of sites is this research currently being conducted?
"There are 8 medical centres offering this study. These include the Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) in Basking Ridge, the Montvale site of Memorial Sloan Kettering Bergen (Limited Protocol Activities), and a limited protocol activity at Memorial Sloan Kettering Cancer Center @ Suffolk in Commack."
Answered by AI
To what extent is this research endeavor accommodating participants?
"Affirmative. Clinicaltrials.gov displays that sign-ups for this trial are in progress, with the initial posting on June 12th 2019 and the most recent update being June 29th 2022. The study needs 53 patients from 8 different medical sites to take part."
Answered by AI
Are additional participants being sought for this investigation?
"Data hosted on clinicaltrials.gov reveals that this study is currently inviting participants to enroll. This trial was first uploaded to the website on June 12th 2019, with its most recent update occurring June 29th 2022."
Answered by AI
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