High Intensity Interval Training in Endometrial Cancer

Not Applicable

Active, not recruiting

• Conditions: Endometrial Cancer
• Interventions: Behavioral: HIIT exercise

• Registration Number: NCT04025229
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2019-05-20
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-09-08
• Study Completion: 2025-09-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIIT exercise	HIIT exercise	Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery

Primary Outcome Measures

Name	Time	Method
Change in proliferative markers in endometrium before and after HIIT exercises	3 years	Ki-67 values in biopsy samples

Trial Locations

Locations (1)

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States