Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors

Solid Tumors Clinical Trial

Official title:

Preoperative Aerobic Training for Solid Tumors (PRESTO 1): A Phase 0/1a Digitized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03813615
• Other study ID #: 18-534
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 21, 2019
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

Phase 0 (Proof-of-Concept)

• Patients with one of the following:
• Early-stage breast cancer having completed participation in IRB# 15-147
• Diagnosed with the prespecified solid tumors: endometrial, breast or prostate cancer
• Underwent a diagnostic lung biopsy within 14 days prior to enrollment
• Age >18 years
• BMI = 40
• Has = 20 mg of fresh normal lung and suspicious lung tissue from the standard of care diagnostic biopsy available for snap freezing and single-cell sequencing (lung patients only)
• At least a 2-week window from study enrollment to scheduled surgical resection (patients with prespecified solid tumors only)
• Performing less than 30 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self report If > 30 minutes but less than 90 minutes, patients may be eligible, at the discretion of the PI.
• Cleared for exercise participation as per screening clearance via PAR-Q+
• Willingness to comply with all study-related procedures Phase 1a (Dose-Finding/Escalation)
• Patients with operable untreated prostate cancer scheduled for surgery
• At least a 2-week window from study enrollment to scheduled surgical resection (patients with prespecified solid tumors only)
• Age > 18 years
• BMI </=40
• If BMI >40, patients may be eligible, at the discretion of the PI
• Performing </= 30 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self report If > 30 minutes but less than 90 minutes, patients may be eligible, at the discretion of the PI.
• Cleared for exercise participation as per screening clearance via PAR-Q+
• Willingness to comply with all study-related procedures

Exclusion Criteria:

• Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of study entry, including, but not limited to: tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole (for preoperative breast, endometrial, and prostate patients in Phase 0 only)
• Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes
• Men receiving GNRH agonists and antagonists as well as any antiandrogrens
• Any neoadjuvant anticancer treatment of any kind for the cancer of interest
• Any history of systemic anticancer therapy
• Any other diagnosis of invasive cancer currently requiring active treatment
• Metastatic malignancy of any kind
• Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.

Related Conditions & MeSH terms

• Neoplasms
• Preoperative Aerobic Training
• Solid Tumors

Intervention

Behavioral:
• treadmill walking (Proof-of-Concept)
Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear dosing schedule for a minimum of 2 weeks. All aerobic training treatment will be implemented and may be monitored using TeleEx. Participants may also perform up to two aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided with Appendix J - Unsupervised Home-Based Exercise Recording Form and Appendix K - Unsupervised Home-Based Exercise Instructions to record their sessions. 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. setting.
• treadmill walking Dose-Finding / Escalation
Six doses of aerobic training ( 90mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/wk & 450mins/wk) delivered following either a standard linear (i.e., each dose of exercise is performed at the same intensity & duration) or non-linear (i.e., exercise dose is continually altered & progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule 3 to 6 times weekly (over a 7-day period) for a minimum 2 weeks. Aerobic training treatment will be implemented & may be monitored using TeleEx. Patients may also perform up to three aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided a plan for their unsupervised session(s) verbally or via Portal Secure Messaging (PSM), as appropriate.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	University of California, Los Angeles (Data Analysis only)	Los Angeles	California
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identify the recommended dose of aerobic training	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center