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High Intensity Interval Training in Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIIT exercise
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Endometrial Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UNC Lineberger Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIIT exercise

Arm Description

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

Outcomes

Primary Outcome Measures

Change in proliferative markers in endometrium before and after HIIT exercises
Ki-67 values in biopsy samples

Secondary Outcome Measures

Full Information

First Posted
July 16, 2019
Last Updated
March 22, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04025229
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
September 8, 2025 (Anticipated)
Study Completion Date
September 8, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will complete HIIT training prior to surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT exercise
Arm Type
Experimental
Arm Description
Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery
Intervention Type
Behavioral
Intervention Name(s)
HIIT exercise
Intervention Description
High intensity interval training (4 to 6 sessions) prior to surgery
Primary Outcome Measure Information:
Title
Change in proliferative markers in endometrium before and after HIIT exercises
Description
Ki-67 values in biopsy samples
Time Frame
3 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study recruits women with endometrial cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Bae-Jump, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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High Intensity Interval Training in Endometrial Cancer

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