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出境医 / 临床实验 / Exercise Treatment With Standard Therapy for Metastatic Breast Cancer
Exercise Treatment With Standard Therapy for Metastatic Breast Cancer
Study Description
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 |
Study Design
| 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 |
Arms and Interventions
| 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.
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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.
|
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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.
|
Outcome Measures
Primary Outcome Measures :
- 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%.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Neil Iyengar, MD | 646-888-4714 | iyengarn@mskcc.org | |
| Contact: Lee Jones, PhD | 646-888-8103 |
Locations
| 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
| Principal Investigator: | Neil Iyengar, MD | Memorial Sloan Kettering Cancer Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 13, 2019 | ||||||||
| First Posted Date ICMJE | June 17, 2019 | ||||||||
| Last Update Posted Date | May 12, 2021 | ||||||||
| Actual Study Start Date ICMJE | June 12, 2019 | ||||||||
| Estimated Primary Completion Date | August 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Exercise Treatment With Standard Therapy for Metastatic Breast Cancer | ||||||||
| Official Title ICMJE | Phase 1a/1b Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Hormone Receptor Positive Metastatic Breast Cancer | ||||||||
| Intervention ICMJE | 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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
60 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 1, 2023 | ||||||||
| Estimated Primary Completion Date | August 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03988595 | ||||||||
| Other Study ID Numbers ICMJE | 19-113 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
| Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
| Verification Date | May 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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