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NCT03813615 · ClinicalTrials.gov registry record · Early Phase 1
Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors
A Early Phase 1 study of Solid Tumors and Preoperative Aerobic Training, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 8
- Study locations
NCT03813615: Active Early Phase 1 study of Solid Tumors and Preoperative Aerobic Training, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03813615 is a Early Phase 1 study of Solid Tumors and Preoperative Aerobic Training that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 60 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (79% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03813615, a Early Phase 1 study of Solid Tumors and Preoperative Aerobic Training, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to find the safest level of aerobic training for people about to undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on these patients and the outcomes of their cancers. This part of the study (Phase 0) will evaluate the feasibility and quality of at-home exercise and assessment procedures and find out whether study participants are willing to practice continuous lifestyle monitoring using apps and electronic devices. Phase 1a will compare the effects and feasibility of six different doses of aerobic exercise and will continue evaluating the quality of at-home study procedures, which includes the use of continuous lifestyle monitoring through apps and electronic devices. In order to facilitate completion of the phase 1a component, we will backfill the 90, 225, and 300 mins/wk dosing cohorts with at least 4 patients in each dose cohort.
Primary Outcome
The relative dose intensity is defined as the ratio of completed to planned aerobic training dose continually assessed at the end of the intervention period.49 Hence, the maximal feasible dose is defined as the highest dose at which \<30% of patients in a dosing cohort fail to achieve the target total cumulative relative dose intensity.
Conditions Studied
Interventions
- BEHAVIORAL treadmill walking (Proof-of-Concept)
- BEHAVIORAL treadmill walking Dose-Finding / Escalation
Study Locations (8)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
California
- University of California, Los Angeles (Data Analysis only) - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-01-21 |
| Est. Completion | 2027-01 |
| Phase | Early Phase 1 |
What the registry record for NCT03813615 still lists
NCT03813615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which treadmill walking (Proof-of-Concept) is the first listed.
NCT03813615 lists 8 locations in 3 states (New York, New Jersey, California).
Frequently Asked Questions
What is clinical trial NCT03813615 about?
NCT03813615 is a clinical study titled "Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors". The purpose of this study is to find the safest level of aerobic training for people about to undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on these patients and the outcomes of their cancers. This part of the study (Phase 0) will evaluate the feasibility ...
What is the current status of trial NCT03813615?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2019-01-21. Estimated completion is 2027-01.
What conditions does trial NCT03813615 study?
This clinical trial studies the following conditions: Solid Tumors, Preoperative Aerobic Training.
What interventions are being tested in trial NCT03813615?
The interventions under investigation include: treadmill walking (Proof-of-Concept) (BEHAVIORAL), treadmill walking Dose-Finding / Escalation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03813615?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03813615 being conducted?
This trial has 8 study locations across California, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03813615's enrollment target sits among peer trials
60 74th of 125 higher than 51 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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