Skip to main content
OpenTrials
Completed

NCT Number: NCT04025229

High Intensity Interval Training in 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

About this study

Primary Objectives:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIIT exercise

Behavioral

High intensity interval training (4 to 6 sessions) prior to surgery

Primary outcomes

  1. Change in Proliferative Markers in Endometrium Before and After HIIT Exercises

    Time frame: 3 years

    Change in Ki-67 proliferation values within the HIIT intervention group between the initial biopsy and the surgical biopsy. The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (>30%): Fast-growing, potentially more aggressive.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2019
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.