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

Early Phase 1

Active, not recruiting

• Conditions: Solid Tumors; Preoperative Aerobic Training
• Interventions: Behavioral: treadmill walking Dose-Finding / Escalation; Behavioral: treadmill walking (Proof-of-Concept)

• Registration Number: NCT03813615
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2019-01-21
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-21
• Study First Posted: 2019-01-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1a: Dose-Finding / Escalation	treadmill walking Dose-Finding / Escalation	Individualized, progressive aerobic training consisting of treadmill walking ranging from a total of 90 mins/wk to 450 mins/wk delivered over 3 to 7 sessions/wk following a linear or non-linear dosing schedule for a minimum of 2 weeks. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion.
Pilot "Proof-of-Concept"	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 (breast, prostate, and endometrial) or non-linear (lung) dosing schedule for a minimum of 2 weeks.

Primary Outcome Measures

Name	Time	Method
identify the recommended dose of aerobic training	1 year	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.

Trial Locations

Locations (8)

University of California, Los Angeles (Data Analysis only); 🇺🇸 Los Angeles, California, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, 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

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States