Aerobic Training in Supporting Patients with Breast, Endometrial, or Prostate Cancer before Surgery

Status: Active

Description

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

Eligibility Criteria

Inclusion Criteria

  • PHASE 0 (PROOF OF CONCEPT)
  • Early-stage breast cancer having completed participation in Institutional Review Board (IRB)# 15-147 or diagnosed with the prespecified solid tumors: endometrial, breast and prostate cancer.
  • Body mass index (BMI) =< 35.
  • At least a 2-week window from study enrollment to scheduled surgical resection (for preoperative patients only).
  • Performing less than 90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self report.
  • Access to an email address or Memorial Sloan Kettering (MSK) portal.
  • Cleared for exercise participation as per screening clearance via Physical Activity Readiness Questionnaire for Everyone (PAR-Q+).
  • Willingness to comply with all study-related procedures.
  • PHASE IA (DOSE-FINDING/ESCALATION) AND PHASE IB (DOSE EXPANSION)
  • Patients with operable untreated endometrial, breast or prostate cancer scheduled for surgery.
  • Availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor slides or fresh tumor tissue, as appropriate
  • All other eligibility criteria are identical to those described for Phase 0.

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 patients only).
  • Enrollment onto any other interventional investigational study.
  • Men receiving gonadotropin-releasing hormone (GNRH) agonists and antagonists as well as any antiandrogens.
  • Any neoadjuvant anticancer treatment of any kind.
  • Any other current diagnosis of invasive cancer of any kind.
  • 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.

Locations & Contacts

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Lee Winston Jones
Phone: 646-888-8103

Trial Objectives and Outline

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 prespecified solid tumors 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 prespecified solid tumors 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-followup, attendance and dose modification. (Phase 0)

IV. To evaluate changes in dynamic physiological measures of heart rate, blood pressure, weight / body composition, and sleep as well as other standard measures (exercise capacity). (Phase 0)

V. To explore the impact of exercise on changes in tumor biology 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 150-300 minutes for 5 sessions each week following a linear or non-linear schedule for 2-6 weeks. Patients may also perform up to 2 home-based, unsupervised aerobic sessions per week.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Lee Winston Jones

Trial IDs

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