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Aerobic Training in Supporting Patients with Solid Tumors before Surgery, PRESTO 1 study

Trial Status: Active

This early phase I trial studies the safest level of aerobic training and to see how well it works in supporting patients with solid tumors who are undergoing surgery. Aerobic exercise may improve the outcomes of their cancers.

Inclusion Criteria

  • PHASE 0 (PROOF OF CONCEPT): Patients with one of the following: * Early-stage breast cancer having completed participation in Institutional Review Board (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
  • PHASE 0 (PROOF OF CONCEPT): Body mass index (BMI) =< 40.
  • PHASE 0 (PROOF OF CONCEPT): Has >= 20 mg of fresh lung and suspicious lung tissue from the standard of care diagnostic biopsy available for single-cell sequencing (lung patients only)
  • PHASE 0 (PROOF OF CONCEPT): At least a 2-week window from study enrollment to scheduled surgical resection (patients with prespecified solid tumors only).
  • PHASE 0 (PROOF OF CONCEPT): 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 principal investigator (PI).
  • PHASE 0 (PROOF OF CONCEPT): Cleared for exercise participation as per screening clearance via Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
  • PHASE 0 (PROOF OF CONCEPT): Willingness to comply with all study-related procedures.
  • PHASE IA (DOSE-FINDING/ESCALATION) AND PHASE IB (DOSE EXPANSION): Patients with operable untreated prostate cancer scheduled for surgery.
  • PHASE IA (DOSE-FINDING/ESCALATION) AND PHASE IB (DOSE EXPANSION): At least a 2-week window from study enrollment to scheduled surgical resection.
  • PHASE IA (DOSE-FINDING/ESCALATION) AND PHASE IB (DOSE EXPANSION): BMI =< 40.
  • PHASE IA (DOSE-FINDING/ESCALATION) AND PHASE IB (DOSE EXPANSION): 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.
  • PHASE IA (DOSE-FINDING/ESCALATION) AND PHASE IB (DOSE EXPANSION): Cleared for exercise participation as per screening clearance via PAR-Q+.
  • PHASE IA (DOSE-FINDING/ESCALATION) AND PHASE IB (DOSE EXPANSION): 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 gonadotropin-releasing hormone (GNRH) agonists and antagonists as well as any antiandrogens.
  • Any neoadjuvant anticancer treatment of any kind for the cancer of interest.
  • Any other diagnosis of invasive cancer currently requiring active treatment.
  • Any history of systemic anticancer therapy.
  • 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.

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Lee Winston Jones
Phone: 646-888-8103
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Lee Winston Jones
Phone: 646-888-8103
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Lee Winston Jones
Phone: 646-888-8103

New York

Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Lee Winston Jones
Phone: 646-888-8103
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Lee Winston Jones
Phone: 646-888-8103
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Lee Winston Jones
Phone: 646-888-8103
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Lee Winston Jones
Phone: 646-888-8103

PRIMARY OBJECTIVES:

I. To establish the logistics of preoperative aerobic training (e.g., rates of patient screening, eligibility, consent, lost to follow-up) and other related study procedures (e.g., delivery of exercise using telemedicine and collection of wireless health data) in patients with prespecified solid tumors. (Phase 0)

II. To determine recommended phase 2 dose (RP2D) (as defined by feasibility, safety, and biological activity) of aerobic training administered to patients with operable untreated prostate cancer during the immediate preoperative period (i.e., from diagnosis to scheduled surgical resection). (Phase Ia)

III. To further evaluate the biological activity (as assessed by changes in Ki67) of the RP2D administered to patients with operable untreated prostate cancer during the immediate preoperative period (i.e., from diagnosis to scheduled surgical resection). (Phase Ib)

SECONDARY OBJECTIVES:

I. To evaluate digitized clinical trial procedures (DCTP) logistics (duration of study overview, consent, and platform orientation, device delivery and installation) and reliability / quality (i.e., connection success rate, patient device use compliance). (Phase 0)

II. To evaluate patient compliance to planned use of digital devices defined as the ratio of total synced data per device to the total number of planned measurements (at least one reading per device per day on study). (Phase 0)

III. To evaluate patient compliance to planned exercise treatment regimen as assessed by rates of lost-to-follow up, attendance and dose modification. (Phase 0)

IV. To explore changes in dynamic physiological measures of heart rate, blood pressure, weight / body composition, and sleep as well as other standard measures (e.g., exercise capacity) and biological (e.g., continuous glucose monitoring, glucose response, circulating immune phenotypes, gut microbiome) correlates. (Phase 0)

V. To explore the impact of exercise on changes in tumor molecular landscape using standard and novel platforms. (Phase 0)

VI. To explore the pharmacodynamics of aerobic training as evaluated by changes in physiological (e.g., exercise capacity, body weight, blood pressure) and biological (e.g., tumor cell proliferation [Ki67], blood-based metabolic profile) correlates. (Phase Ia)

VII. To further evaluate safety, feasibility, and pharmacodynamics. (Phase Ib)

VIII. Explore factors associated with change in Ki67. (Phase Ib)

OUTLINE: This is a dose-escalation study.

Patients perform individualized, home-based treadmill walking over 90-450 minutes for 3-7 sessions each week following a linear or non-linear schedule for 2-6 weeks. Patients may also perform up to 3 home-based, unsupervised aerobic sessions per week.

Trial Phase Phase O

Trial Type Treatment

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Lee Winston Jones

  • Primary ID 18-534
  • Secondary IDs NCI-2019-01425
  • Clinicaltrials.gov ID NCT03813615