High Intensity Interval Training in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
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

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.

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

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Behavioral: HIIT exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will complete HIIT training prior to surgery
Masking: None (Open Label)


Arms and Interventions

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

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 |