[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05903131":3,"trial-entities:NCT05903131":172,"trial-summary:NCT05903131":176},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":57,"secondary_outcomes":61,"sex":80,"minimum_age":81,"maximum_age":17,"healthy_volunteers":82,"eligibility_criteria":83,"std_ages":100,"locations":103,"central_contacts":163,"overall_officials":165,"references":167,"see_also_links":168},"NCT05903131","202307204","Uterine Preservation Via Lifestyle Transformation","UPLifT-Endo: Uterine Preservation Via Lifestyle Transformation A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Atypical Endometrial Hyperplasia or Grade 1 Endometrial Cancer","RECRUITING","2029-10-31","2026-01","2026-01-20","2024-10-24","Washington University School of Medicine","OTHER",true,"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 AEH desire uterine preservation will be more likely to have atypia-free uterine preservation at one year if they receive progestin in combination with a behavioral weight loss intervention versus progestin plus enhanced usual care.",null,[19,20],"Endometrial Hyperplasia","Grade 1 Endometrial Cancer",[22,23,24,25,26,27,28],"fertility-sparing","weight management","obesity","endometrial cancer","behavioral intervention","premenopausal endometrial hyperplasia","premenopausal endometrial cancer","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},96,"ESTIMATED",[37,43,48,53],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","Telemedicine behavioral weight intervention","Weekly telephone calls during the first month, biweekly during the next 5 months, and then monthly for the last 7 months (12 months total). Each telephone session will be 30 minutes long.",[42],"Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention",{"type":44,"name":45,"description":46,"armGroupLabels":47},"DRUG","Progestin","Released via the levonorgestrel-releasing IUD.",[42],{"type":38,"name":49,"description":50,"armGroupLabels":51},"Enhanced usual care","1-3 page handouts",[52],"Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care",{"type":44,"name":54,"description":55,"armGroupLabels":56},"Levonorgestrel-releasing IUD.","Standard of care",[42,52],[58],{"measure":59,"timeFrame":60},"Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy","At 1 year",[62,66,68,71,74,76],{"measure":63,"description":64,"timeFrame":65},"Time to resolution of atypical endometrial hyperplasia (AEH)","Defined as the period of time in months\u002Fdays from the first biopsy to show AEH or grade 1 endometrial cancer to the first biopsy that shows no evidence of hyperplasia or malignancy","Through completion of follow-up (estimated to be 2 years)",{"measure":67,"timeFrame":65},"Time to resolution of endometrial cancer",{"measure":69,"description":70,"timeFrame":65},"Atypia-free survival","-Defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of atypical endometrial hyperplasia (AEH) recurrence. AEH-free or the patients with lost to follow-up will be censored at the last follow-up.",{"measure":72,"description":73,"timeFrame":65},"Endometrial cancer progression-free survival (EC-PFS)","EC-PFS is defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of recurrence of EC. Endometrial cancer-free patients or the patients with lost to follow-up will be censored at the last follow-up.",{"measure":75,"timeFrame":65},"Change in weight",{"measure":77,"description":78,"timeFrame":79},"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.","At enrollment, 6 months, 12 months, end of intervention, and 24 months (estimated to be 2 years)","FEMALE","18 Years",false,{"inclusion":84,"exclusion":95,"raw_text":99},[85,86,87,88,89,90,91,92,93,94],"Diagnosis of histologically confirmed complex atypical endometrial hyperplasia (AEH) 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 documented.","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.","Undergoing uterine-sparing management (e.g. due to interest in fertility preservation, interest in uterine preservation, provider recommendation, or other reason).","BMI ≥ 30 kg\u002Fm\\^2.","Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.","Ability to understand and willingness to sign an IRB approved written informed consent document.",[96,97,98],"Current, active treatment for any malignant neoplasm with chemotherapy or radiation.","Pregnant and\u002For breastfeeding. Participants must have a negative urine or serum pregnancy test during screening window and within 7 days prior to LNG-IUD insertion. If LNG-IUD is in place, lack of pregnancy is assumed.","Active pelvic infection at the time of IUD placement or other contraindication to the use of an IUD in the opinion of the treating physician.","Inclusion Criteria:\n\n* Diagnosis of histologically confirmed complex atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer.\n\n  * 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.\n  * 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 documented.\n* Premenopausal woman with a uterus.\n* ECOG performance status of 0-2.\n* At least 18 years of age and no more than 45 years of age.\n* Undergoing uterine-sparing management (e.g. due to interest in fertility preservation, interest in uterine preservation, provider recommendation, or other reason).\n* BMI ≥ 30 kg\u002Fm\\^2.\n* Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Current, active treatment for any malignant neoplasm with chemotherapy or radiation.\n* Pregnant and\u002For breastfeeding. Participants must have a negative urine or serum pregnancy test during screening window and within 7 days prior to LNG-IUD insertion. If LNG-IUD is in place, lack of pregnancy is assumed.\n* Active pelvic infection at the time of IUD placement or other contraindication to the use of an IUD in the opinion of the treating physician.",[101,102],"ADULT","OLDER_ADULT",[104,135,150],{"facility":13,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":132},"St Louis","Missouri","63110","United States",[110,115,117,120,122,124,126,128,130],{"name":111,"role":112,"phone":113,"email":114},"Andrea R Hagemann, M.D., MSCI","CONTACT","314-362-1763","hagemanna@wustl.edu",{"name":111,"role":116},"PRINCIPAL_INVESTIGATOR",{"name":118,"role":119},"Graham Colditz, M.D., DrPH","SUB_INVESTIGATOR",{"name":121,"role":119},"Ian Hagemann, M.D., Ph.D.",{"name":123,"role":119},"David Mutch, M.D.",{"name":125,"role":119},"Esther Lu, Ph.D.",{"name":127,"role":119},"Gary Patii, Ph.D.",{"name":129,"role":119},"David Morris, Ph.D.",{"name":131,"role":119},"Veronica Davé, Ph.D.",{"lat":133,"lon":134},38.62727,-90.19789,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":108,"contacts":140,"geoPoint":147},"University of New Mexico","Albuquerque","New Mexico","87106",[141,144,145],{"name":142,"role":112,"phone":143},"Carolyn Muller, M.D.","505-272-2111",{"name":142,"role":116},{"name":146,"role":119},"Kimberly Leslie, M.D.",{"lat":148,"lon":149},35.08449,-106.65114,{"facility":151,"status":8,"city":152,"state":153,"zip":154,"country":108,"contacts":155,"geoPoint":160},"University of Oklahoma","Oklahoma City","Oklahoma","73104",[156,159],{"name":157,"role":112,"phone":158},"Kathleen Moore, M.D., MS","405-271-8707",{"name":157,"role":116},{"lat":161,"lon":162},35.46756,-97.51643,[164],{"name":111,"role":112,"phone":113,"email":114},[166],{"name":111,"affiliation":13,"role":116},[],[169],{"label":170,"url":171},"Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine","http:\u002F\u002Fwww.siteman.wustl.edu",{"nct_id":4,"conditions":173,"biomarkers":175},[174,19],"Endometrial Carcinoma",[],{"nct_id":4,"found":15,"summary":177,"prompt_version":187},{"design":178,"status":179,"heading":180,"summary":181,"follow_up":182,"word_count":183,"commitments":184,"compensation":185,"drugs_mentioned":186},"This is an interventional study with 96 planned participants. It compares a telemedicine behavioral weight intervention plus a levonorgestrel-releasing IUD to enhanced usual care plus a levonorgestrel-releasing IUD.","completed","Uterine Preservation Via Lifestyle Transformation for Endometrial Hyperplasia or Grade 1 Endometrial Cancer","This study is for women with atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer. It aims to see if a telemedicine behavioral weight intervention, combined with a levonorgestrel-releasing IUD (a device that releases progestin, a hormone), can help preserve the uterus. Some participants will receive the telemedicine intervention and IUD, while others will receive enhanced usual care (handouts) and the IUD. Researchers want to find out how many participants are free of AEH after one year. This study is exploring ways to manage these conditions without surgery, especially for women who want to maintain their fertility. The current recruitment status is unclear, but the study plans to enroll 96 participants.","Participants will be assessed at 1 year to see if they are free of atypical endometrial hyperplasia.",111,"Participants receiving the telemedicine behavioral weight intervention will have weekly telephone calls for the first month, biweekly for the next 5 months, and then monthly for 7 months (12 months total). Each call will be 30 minutes long. All participants will receive a levonorgestrel-releasing IUD.","Not stated in the trial record.",[39,45,49],"v2"]