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出境医 / 临床实验 / High Intensity Interval Training in Endometrial Cancer
High Intensity Interval Training in Endometrial Cancer
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
| 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. 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 Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Participants will complete HIIT training prior to surgery |
| 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, 2022 |
| Estimated Study Completion Date : | May 20, 2023 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- Change in proliferative markers in endometrium before and after HIIT exercises [ Time Frame: 3 years ]Ki-67 values in biopsy samples
Eligibility Criteria
| 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.
Contacts and Locations
Contacts
| Contact: Luz Cuaboy | 919-966-7051 | luz_cuaboy@med.unc.edu | |
| Contact: Abbie Smith-Ryan, PhD | 919-962-2574 | abbsmith@email.unc.edu |
Locations
| 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
| Principal Investigator: | Victoria Bae-Jump, MD | University of North Carolina, Chapel Hill |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 16, 2019 | ||||||||
| First Posted Date ICMJE | July 18, 2019 | ||||||||
| Last Update Posted Date | June 3, 2021 | ||||||||
| Actual Study Start Date ICMJE | May 20, 2019 | ||||||||
| Estimated Primary Completion Date | May 20, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in proliferative markers in endometrium before and after HIIT exercises [ Time Frame: 3 years ] Ki-67 values in biopsy samples
|
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | High Intensity Interval Training in Endometrial Cancer | ||||||||
| Official Title ICMJE | Pre-operative Window Study of Interval Exercise Training as a Therapy for Endometrial Cancer | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Participants will complete HIIT training prior to surgery Masking: None (Open Label)Primary Purpose: Other |
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| Condition ICMJE | Endometrial Cancer | ||||||||
| Intervention ICMJE | Behavioral: HIIT exercise
High intensity interval training (4 to 6 sessions) prior to surgery
|
||||||||
| Study Arms ICMJE | Experimental: HIIT exercise
Participants will perform HIIT exercises as instructed by the study team in the weeks prior to standard of care surgery
Intervention: Behavioral: HIIT exercise
|
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE |
44 | ||||||||
| Estimated Study Completion Date ICMJE | May 20, 2023 | ||||||||
| Estimated Primary Completion Date | May 20, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
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:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04025229 | ||||||||
| Other Study ID Numbers ICMJE | LCCC 1839 1R21CA235029-01 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | UNC Lineberger Comprehensive Cancer Center | ||||||||
| Study Sponsor ICMJE | UNC Lineberger Comprehensive Cancer Center | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| PRS Account | UNC Lineberger Comprehensive Cancer Center | ||||||||
| Verification Date | May 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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