search
Back to results

A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

Primary Purpose

Endometrial Hyperplasia, Grade 1 Endometrial Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telemedicine behavioral weight intervention
Progestin
Enhanced usual care
Levonorgestrel-releasing IUD.
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometrial Hyperplasia focused on measuring fertility-sparing, weight management, obesity, endometrial cancer, behavioral intervention, premenopausal endometrial hyperplasia, premenopausal endometrial cancer

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of histologically confirmed complex atypical endometrial hyperplasia or grade 1 endometrial cancer. Patients with a previous diagnosis of AEH or grade 1 endometrial cancer who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible. For patients with a previous diagnosis of AEH or grade 1 endometrial cancer who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be less than or equal to 6 months. Premenopausal woman with a uterus. ECOG performance status of 0-2. At least 18 years of age and no more than 45 years of age. Interested in uterine preservation/fertility-sparing treatment. BMI ≥ 30 kg/m^2. Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry. Prior or current receipt of metformin is allowed. Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: Prior participation in a weight loss intervention trial within 3 months prior to date of registration. Current, active treatment for any malignant neoplasm with chemotherapy or radiation. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Pregnant and/or breastfeeding. Participants must have a negative serum pregnancy test within 7 days of date of registration.

Sites / Locations

  • Washington University School of Medicine
  • University of New Mexico
  • University of Oklahoma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention

Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care

Arm Description

The levonorgestrel-releasing IUD is used in this study as per standard care. The behavioral weight loss intervention consists of a telemedicine cognitive behavioral coaching program. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week.

The levonorgestrel-releasing IUD is used in this study as per standard care. Participants will be provided with 1- to 3-page handouts on topics including healthy eating, exercise, and behavioral eating strategies from materials provided on the American Cancer Society, Society of Gynecologic Oncology, and WebMD Nourish websites. These materials encourage weight loss through calorie counting, recording dietary intake, engaging in exercise programs, and using portion control strategies. If participants in the enhanced usual care group do not achieve atypia-free uterine preservation (i.e., have not resolved their hyperplasia or grade 1 endometrial cancer) by one year of enrollment and continue to desire uterine preservation with progestin treatment, they will cross over to receive the telemedicine behavioral intervention for the second year.

Outcomes

Primary Outcome Measures

Number of participants with atypia-free biopsy with uterine preservation

Secondary Outcome Measures

Atypia-free survival
Endometrial cancer-free survival
Change in weight
Change in Cancer Worry Impact Events Scale (CWIES)
The CWIES is a 15-item self-report measure evaluating stress reactions and traumatic experiences, specifically inquiring about cancer worry-specific distress. Range of values for each individual item will be a Likert Scale from 0-5. 0=not at all and 5=often. The higher the score, the more cancer-worry specific distress the participant has.

Full Information

First Posted
May 24, 2023
Last Updated
June 15, 2023
Sponsor
Washington University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT05903131
Brief Title
A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia
Official Title
A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2028 (Anticipated)
Study Completion Date
October 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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

5. Study Description

Brief Summary
Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. The increasing prevalence of obesity in premenopausal women has resulted in increasing rates of AEH in this age group. Hysterectomy with removal of the fallopian tubes and ovaries is 100% effective in preventing endometrial cancer, but this approach results in infertility. Fertility-sparing treatments exist, such as treatment with oral or intrauterine progestin, but these treatments do not work uniformly and do not combat the underlying cause of endometrial cancer, which is obesity and metabolic syndrome. Additionally, up to 41% of women on progestin eventually experience relapse of AEH or endometrial cancer. Third, many patients have insulin resistance that may worsen with progestin therapy. Thus, to improve treatment of AEH and grade 1 endometrial cancer, prevent and reverse endometrial cancer, and allow women to preserve their fertility, the investigators must integrate an effective weight loss strategy to be given with progestin treatment. It is the hypothesis that premenopausal women with endometrial hyperplasia or grade 1 endometrial cancer who desire uterine preservation will be more likely to have atypia-free uterine preservation at two years if they receive progestin in combination with a behavioral weight loss intervention versus progestin plus enhanced usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia, Grade 1 Endometrial Cancer
Keywords
fertility-sparing, weight management, obesity, endometrial cancer, behavioral intervention, premenopausal endometrial hyperplasia, premenopausal endometrial cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention
Arm Type
Experimental
Arm Description
The levonorgestrel-releasing IUD is used in this study as per standard care. The behavioral weight loss intervention consists of a telemedicine cognitive behavioral coaching program. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week.
Arm Title
Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
The levonorgestrel-releasing IUD is used in this study as per standard care. Participants will be provided with 1- to 3-page handouts on topics including healthy eating, exercise, and behavioral eating strategies from materials provided on the American Cancer Society, Society of Gynecologic Oncology, and WebMD Nourish websites. These materials encourage weight loss through calorie counting, recording dietary intake, engaging in exercise programs, and using portion control strategies. If participants in the enhanced usual care group do not achieve atypia-free uterine preservation (i.e., have not resolved their hyperplasia or grade 1 endometrial cancer) by one year of enrollment and continue to desire uterine preservation with progestin treatment, they will cross over to receive the telemedicine behavioral intervention for the second year.
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine behavioral weight intervention
Intervention Description
Weekly telephone calls during the first month, biweekly during the next 5 months, and then monthly for the last 7 months (13 months total). Each telephone session will be 30 minutes long.
Intervention Type
Drug
Intervention Name(s)
Progestin
Intervention Description
Released via the levonorgestrel-releasing IUD.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
1-3 page handouts
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel-releasing IUD.
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
Number of participants with atypia-free biopsy with uterine preservation
Time Frame
At 2 years (or exit from study)
Secondary Outcome Measure Information:
Title
Atypia-free survival
Time Frame
Through completion of follow-up (estimated to be 4 years)
Title
Endometrial cancer-free survival
Time Frame
Through completion of follow-up (estimated to be 4 years)
Title
Change in weight
Time Frame
From baseline to 2 years
Title
Change in Cancer Worry Impact Events Scale (CWIES)
Description
The CWIES is a 15-item self-report measure evaluating stress reactions and traumatic experiences, specifically inquiring about cancer worry-specific distress. Range of values for each individual item will be a Likert Scale from 0-5. 0=not at all and 5=often. The higher the score, the more cancer-worry specific distress the participant has.
Time Frame
At enrollment, 12 months, and end of treatment (estimated to be 2 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of histologically confirmed complex atypical endometrial hyperplasia or grade 1 endometrial cancer. Patients with a previous diagnosis of AEH or grade 1 endometrial cancer who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible. For patients with a previous diagnosis of AEH or grade 1 endometrial cancer who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be less than or equal to 6 months. Premenopausal woman with a uterus. ECOG performance status of 0-2. At least 18 years of age and no more than 45 years of age. Interested in uterine preservation/fertility-sparing treatment. BMI ≥ 30 kg/m^2. Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry. Prior or current receipt of metformin is allowed. Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: Prior participation in a weight loss intervention trial within 3 months prior to date of registration. Current, active treatment for any malignant neoplasm with chemotherapy or radiation. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Pregnant and/or breastfeeding. Participants must have a negative serum pregnancy test within 7 days of date of registration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea R Hagemann, M.D., MSCI
Phone
314-362-1763
Email
hagemanna@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea R Hagemann, M.D., MSCI
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea R Hagemann, M.D., MSCI
Phone
314-362-1763
Email
hagemanna@wustl.edu
First Name & Middle Initial & Last Name & Degree
Andrea R Hagemann, M.D., MSCI
First Name & Middle Initial & Last Name & Degree
Graham Colditz, M.D., DrPH
First Name & Middle Initial & Last Name & Degree
Ian Hagemann, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
David Mutch, M.D.
First Name & Middle Initial & Last Name & Degree
Esther Lu, Ph.D.
First Name & Middle Initial & Last Name & Degree
Gary Patii, Ph.D.
First Name & Middle Initial & Last Name & Degree
David Morris, Ph.D.
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Muller, M.D.
Phone
505-272-2111
First Name & Middle Initial & Last Name & Degree
Carolyn Muller, M.D.
First Name & Middle Initial & Last Name & Degree
Kimberly Leslie, M.D.
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Moore, M.D., MS
Phone
405-271-8707
First Name & Middle Initial & Last Name & Degree
Kathleen Moore, M.D., MS

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

We'll reach out to this number within 24 hrs