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High Intensity Interval Training in Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT04025229
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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. Participants will be randomized into two arms: HIIT training and no HIIT training

Condition or disease Intervention/treatment Phase
Endometrial Cancer Behavioral: HIIT exercise Not Applicable

Detailed Description:

Primary Objectives:

  1. Determine the anti-proliferative effect of HIIT on the endometrium of women with endometrial cancer
  2. Compare the change in proliferation between initial biopsy and biopsy at surgery in EC patients in the HIIT intervention to the same samples in the standard of care control group.

Participants randomized to HIIT training will undergo baseline testing, be taught how to perform personalized HIIT training prior to surgery, and repeat testing after surgery. Participants on the no HIIT training arm will undergo baseline testing 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to two arms: Those who complete HIIT training prior to surgery, and those who do not complete HIIT training prior to sugery
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pre-operative Window Study of Interval Exercise Training as a Therapy for Endometrial Cancer
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : May 20, 2021
Estimated Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIIT exercise
Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery
Behavioral: HIIT exercise
High intensity interval training (4 to 6 sessions) prior to surgery

No Intervention: No HIIT exercise
Participants will not perform exercises prior to surgery.



Primary Outcome Measures :
  1. Change in proliferative markers in endometrium before and after HIIT exercises [ Time Frame: 3 years ]
    Ki-67 values in biopsy samples

  2. Change in proliferation markers in endometrium in HIIT compared to control group [ Time Frame: 3 years ]
    Ki -67 values in biopsy samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study recruits women with endometrial cancer
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025229


Contacts
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Contact: Luz Cuaboy 919-966-7051 luz_cuaboy@med.unc.edu
Contact: Abbie Smith-Ryan, PhD 919-962-2574 abbsmith@email.unc.edu

Locations
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United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Luz Cuaboy    919-966-7051    luz_cuaboy@med.unc.edu   
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Victoria Bae-Jump, MD University of North Carolina, Chapel Hill

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04025229     History of Changes
Other Study ID Numbers: LCCC 1839
1R21CA235029-01 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female