Clinical trial NCT04025229: High Intensity Interval Training in Endometrial Cancer
Official title: Pre-operative Window Study of Interval Exercise Training as a Therapy for Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-18
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will complete HIIT training prior to surgery
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in proliferative markers in endometrium before and after HIIT exercises
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Victoria Bae-Jump, MD
role: PRINCIPAL_INVESTIGATOR
References: