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Trial record 1 of 1 for:    NCT03988595
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Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT03988595
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive Metastatic Breast Cancer Other: Exercise Treatment Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Exercise therapy will consist of individualized walking delivered 3 to 5 times weekly for 24 weeks. This trial will evaluate four escalated doses of exercise (90 mins/wk, 150 mins/wk, 225 mins/wk, or 300 mins/week).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1a/1b Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aerobic training 90 mins/wk
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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.
Other: Exercise Treatment
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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.

Experimental: aerobic training 150 mins/wk
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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.
Other: Exercise Treatment
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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.

Experimental: aerobic training 225 mins/wk
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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.
Other: Exercise Treatment
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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.

Experimental: aerobic training 300 mins/week
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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.
Other: Exercise Treatment
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 across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. 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.




Primary Outcome Measures :
  1. maximum feasible dose (MFD) [ Time Frame: 24 weeks ]
    Feasibility is defined in terms of the relative dose intensive (RDI), the proportion of the planned exercise prescription that was completed without requiring a dose modification or interruption. The MFD is defined as the dose estimated to result in approximately 70% of patients achieving an RDI ≥ 75%.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast Cancer
Accepts Healthy Volunteers:   No
Criteria

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)
  • ECOG performance status of 0 to 1 or KPS of 80% - 100%
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988595


Contacts
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Contact: Neil Iyengar, MD 646-888-4714 iyengarn@mskcc.org
Contact: Lee Jones, PhD 646-888-8103

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Neil Iyengar, MD    646-888-4714      
Memoral Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Neil Iyengar, MD    646-888-4714      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Neil Iyengar, MD    646-888-4714      
United States, New York
Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only) Recruiting
Bronx, New York, United States, 10467
Contact: Jesus Anampa Mesias, MD    866-633-8255      
Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity) Recruiting
Commack, New York, United States, 11725
Contact: Neil Iyengar, MD    646-888-4714      
Memoral Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Neil Iyengar, MD    646-888-4714      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Neil Iyengar, MD    646-888-4714      
Contact: Lee Jones, PhD    646-888-8103      
Principal Investigator: Neil Iyengar, MD         
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Neil Iyengar, MD    646-888-4714      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Neil Iyengar, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03988595    
Other Study ID Numbers: 19-113
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Exercise
19-113
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases