High Intensity Interval Training in Endometrial Cancer

Pre-operative Window Study of Interval Exercise Training as a Therapy for Endometrial Cancer

This interventional trial recruits women with endometrial cancer to participate in high intensity interval training (HIIT) prior to their standard of care surgery. The study will evaluate tissue and blood to determine if HIIT training has anti-cancer effects. P

Study Overview

• Status: Active, not recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Behavioral: HIIT exercise

Detailed Description

Primary Objectives:

1. Determine the anti-proliferative effect of HIIT on the endometrium of women with endometrial cancer 2. Participants will undergo baseline testing, be taught how to perform personalized HIIT training prior to surgery, and repeat testing after surgery. Tissue specimens will be collected from standard of care biopsy (no extra biopsy needed) and during surgery. Blood will be collected twice during standard of care blood draws.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luz Cuaboy; Phone Number: 919-966-7051; Email: luz_cuaboy@med.unc.edu
• Study Contact Backup: Name: Abbie Smith-Ryan, PhD; Phone Number: 919-962-2574; Email: abbsmith@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a diagnosis of endometrial cancer who are to undergo hysterectomy and staging
• Between 40-75 years old
• Body mass index of 30-50 kg/m2
• Endometrioid histology endometrial cancer
• Presumed clinically early stage disease (disease confined to uterus only)
• Have access to a Smart Phone
• Have access to email
• Agree to visit the exercise and sport science laboratory within 2 days of SOC visit for baseline testing if enrollment procedures cannot be done on the same day.

Agree to visit clinic 2 (+/-2wks) weeks after surgery for SOC follow-up and post surgery visit, or willing to return to exercise and sport science laboratory 2 (+/-2wks) weeks post-surgery

Exclusion Criteria:

• Meets American College of Sports Medicine Guidelines for physical activity (150 minutes / week)
• Currently doing HIIT
• Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
• Active diagnosis of psychosis or current uncontrolled substance abuse disorder
• Insulin-dependent diabetes
• Currently in another EC intervention
• Severe dementia or other memory loss condition
• Severe mental health disorder
• Severely impaired hearing or speech
• Inability to speak English
• Musculoskeletal or neuromuscular condition that limits physical activity Any condition, in the opinion of the investigators, which would prohibit safe participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIIT exercise; Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery	Behavioral: HIIT exercise; High intensity interval training (4 to 6 sessions) prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proliferative markers in endometrium before and after HIIT exercises	Ki-67 values in biopsy samples	3 years

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Victoria Bae-Jump, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Estimated): September 8, 2025
• Study Completion (Estimated): September 8, 2025

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: LCCC 1839; 1R21CA235029-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No