High Intensity Interval Training in Endometrial Cancer

NCT ID: NCT04025229

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2024-09-08

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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HIIT exercise

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

Group Type: EXPERIMENTAL

HIIT exercise

Intervention Type: BEHAVIORAL

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

Interventions

HIIT exercise

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Bae-Jump, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21CA235029-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC 1839

Identifier Type: -

Identifier Source: org_study_id