Aerobic Exercise in Changing Biomarkers in Patients with Solid Tumors or Clonal Hematopoiesis

Status: Active

Description

This trial studies the effect of aerobic exercise in changing biomarkers in patients with solid tumors or clonal hematopoiesis, a condition in which some of the patients' blood cells have a different genetic pattern than the rest of the blood cells. Aerobic exercise stimulates and strengthens the heart and lungs, and improves the body’s use of oxygen. This may help prevent or slow the growth of tumors by changing the biomarkers (signs of disease) found in the blood or by preventing recurrence of certain cancers.

Eligibility Criteria

Inclusion Criteria

  • COHORT 1 (CH): CH called by Memorial Sloan Kettering (MSK) practices as documented by an MSK physician
  • COHORT 1 (CH): Completion of all anticancer therapy
  • COHORT 1 (CH): High risk of cardiovascular disease defined by presence of at least one of the following: * Age > 60 * Prior anthracycline treatment * Prior left-sided breast and/or chest wall radiotherapy * Currently receiving or previously received androgen deprivation therapy * Prior bone marrow transplant * History of smoking
  • COHORT 1 (CH): Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
  • COHORT 1 (CH): Willingness to comply with all study-related procedures
  • COHORT 2 (SOLID TUMOR): Patients at risk of harboring circulating tumor DNA as defined by one of the following: * Histologically confirmed stage III (i.e., high risk of recurrence) colorectal cancer within 2 years of completion of all adjuvant therapy * Histologically confirmed stage III breast cancer with residual disease after neoadjuvant therapy and within 12 months of completing (neo)adjuvant chemotherapy * Patients with metastatic breast cancer and radiographic stable disease or no evidence of disease (NED) for >= 6 months and not currently receiving chemotherapy (endocrine therapy and anti-HER2 antibodies allowed)
  • COHORT 2 (SOLID TUMOR): Adequate formalin-fixed paraffin-embedded (FFPE) tumor block/slides from surgery
  • COHORT 2 (SOLID TUMOR): Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
  • COHORT 2 (SOLID TUMOR): Willingness to comply with all study-related procedures

Exclusion Criteria

  • Concurrent use of any form of antitumor therapy (endocrine therapy and anti-HER2 antibodies allowed for breast patients)
  • Enrollment onto any other interventional investigational study
  • Any other current diagnosis of invasive cancer or hematologic cancer 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
  • Mental impairment leading to inability to cooperate
  • Any of the following contraindications to exercise: * Acute myocardial infarction within 3–5 days of any planned study procedures * Unstable angina * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Symptomatic severe aortic stenosis * Uncontrolled heart failure * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures * Thrombosis of lower extremities within 3 months of any planned study procedures * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Respiratory failure * Acute non-cardiopulmonary disorders that may affect exercise performance
  • Room air desaturation at rest =< 85%

Locations & Contacts

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Neil M. Iyengar
Phone: 646-888-8103
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Neil M. Iyengar
Phone: 646-888-8103
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Neil M. Iyengar
Phone: 646-888-8103

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Neil M. Iyengar
Phone: 646-888-8103
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Neil M. Iyengar
Phone: 646-888-8103
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Neil M. Iyengar
Phone: 646-888-8103
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Neil M. Iyengar
Phone: 646-888-8103

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To explore the biological activity of exercise as evaluated by changes in clonal hematopoiesis (CH) burden quantified by the variant allele frequency (VAF) of CH mutations (measured by targeted CH panel in peripheral blood). (Cohort 1 [CH])

II. To explore the biological activity of exercise as evaluated by changes in residual tumor burden quantified by the amount of circulating tumor deoxyribonucleic acid (DNA) (ctDNA). (Cohort 2 [solid tumor])

SECONDARY OBJECTIVES:

I. To explore the pharmacodynamics of exercise as evaluated by changes in physiological correlates (e.g., exercise capacity, body weight, blood pressure, arterial stiffness). (Cohort 1)

II. To assess safety and tolerability. (Cohorts 1 & 2)

III. To explore the effect on tumor genetic landscape by tracking non-synonymous somatic mutations identified in baseline ctDNA. (Cohort 2)

IV. To explore the pharmacodynamics of exercise as evaluated by changes in physiological correlates (e.g., exercise capacity, body weight, blood pressure). (Cohort 2)

OUTLINE:

Patients receive an electronic tablet device and a kit that includes an activity tracker, heart rate monitor, blood pressure cuff, and scale, and complete an individualized exercise program consisting of walking on a treadmill for 60 minutes, 5 times weekly for up to 52 weeks. Patients also undergo collection of blood samples for CH and ctDNA biomarker analysis.

After completion of study, patients are followed up at 2 weeks.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Neil M. Iyengar

Trial IDs

Primary ID 19-126
Secondary IDs NCI-2019-04294
Clinicaltrials.gov ID NCT03996239