High Intensity Interval Training in Endometrial Cancer

NCT04025229 | Completed Results DMC

• 2 other identifiers: LCCC 18391R21CA235029-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Proliferative Markers in Endometrium Before and After HIIT Exercises

  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.

  3 years

Study Arms (1)

HIIT exercise

EXPERIMENTAL

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

Behavioral: HIIT exercise

Interventions

HIIT exercise BEHAVIORAL

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

HIIT exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: This study recruits women with endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Luz Andrea Cuaboy
• Organization: UNC Lineberger Comprehensive Cancer Center

luz_cuaboy@med.unc.edu

1-919-843-1177

Study Officials

• Victoria Bae-Jump, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will complete HIIT training prior to surgery

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: September 23, 2019
• Primary Completion: September 8, 2024
• Study Completion: September 8, 2024
• Last Updated: October 15, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-10

Locations

US (1)