RECRUITING

A Study of a Weight Loss Intervention in People With Endometrial Cancer

Conditions

Endometrial Cancer tirzepatide semaglutide dual GIP/GLP-1 receptor obesity overweight diabetes stage I-III endometrial cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The researchers are doing this study is to find out whether tirzepatide and semaglutide are practical (feasible) for weight management and blood sugar control for endometrial cancer patients undergoing chemotherapy. The researchers will also look at participants' experience with the study drug, the safety of taking the study drug while receiving chemotherapy, and changes in weight, body fat composition, and blood pressure of participants.

Official Title

Pilot Weight Loss Intervention With Dual GIP/GLP-1 Receptor Agonist Therapy in Patients With Endometrial Cancer and Obesity, Overweight, With or Without Diabetes

Quick Facts

Study Start:2024-12-19

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06751589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Obesity (defined as BMI ≥ 30 kg/m2) OR Overweight (defined as BMI ≥ 27 kg/m2) with presence of ≥1 weight related comorbid condition OR a diagnosis of Type 2 Diabetes Mellitus with BMI ≥ 25 kg/m2 * Type 2 Diabetes Mellitus is defined as known history of Type 2 diabetes, HbA1c ≥ 6.5%, fasting blood glucose ≥126 mg/dL on 2 occasions, or random blood glucose ≥ 200 mg/dL with signs and symptoms of diabetes mellitus (weight loss, fatigue, polyuria, polydipsia, vision changes) * Patients with new diagnosis of stage I-III endometrial cancer * Completed surgery with TH/BSO with no gross residual disease * Recommended to undergo curative intent adjuvant chemotherapy at MSK with carboplatin and paclitaxel with or without intravaginal radiation OR cisplatin and concurrent radiation followed by carboplatin and paclitaxel. Patients may consent prior to and up to 3 weeks after the first cycle of chemotherapy. * Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, carcinosarcoma, undifferentiated carcinoma/de-differentiated, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), and mucinous adenocarcinoma. * Patient has adequate organ function, as defined by the following laboratory values: 1. Creatinine clearance (per Cockcroft-Gault formula) ≥30 mL/min 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN. 3. Total serum bilirubin ≤ 1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN. * Insurance approval for tirzepatide or semaglutide (alternative) or willingness to pay out-of-pocket for tirzepatide or semaglutide (alternative) for duration of study period * Patients must be capable and willing to learn how to self-inject study drug, as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject study drug) and administer study drug injection (or receive an injection from a trained individual if visually impaired or with physical limitations) * Not pregnant and not nursing * English speaking or a family member or caregiver who speaks English and is able to assist with smart phone or tablet based Keenoa app or paper dietary recall handout (if no access to smart phone or tablet).	* Known Type 1 diabetes * Known GAD, Islet Cell, or Zn Transporter 8 antibodies * History of gastroparesis * High risk for aspiration * Active or history of chronic or acute pancreatitis * History of elevated calcitonin * Personal or family history of Medullary Thyroid Carcinoma with Multiple Endocrine Neoplasia-2 syndrome * Patients with a prior surgical, endoscopic, and/or device-based therapy (for example, mucosal ablation, gastric artery embolization, intragastric balloon and duodenojejunal bypass sleeve) for obesity within the past two years * Patients with removal of device-based therapy for obesity within the last 6 months * Current GIP/GLP-1 or GLP-1 receptor agonist use or prior intolerance of GIP/GLP-1 or GLP-1 receptor agonist * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Known intolerance to study drug(s) or any of the excipients.

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Obesity (defined as BMI ≥ 30 kg/m2) OR Overweight (defined as BMI ≥ 27 kg/m2) with presence of ≥1 weight related comorbid condition OR a diagnosis of Type 2 Diabetes Mellitus with BMI ≥ 25 kg/m2
* Type 2 Diabetes Mellitus is defined as known history of Type 2 diabetes, HbA1c ≥ 6.5%, fasting blood glucose ≥126 mg/dL on 2 occasions, or random blood glucose ≥ 200 mg/dL with signs and symptoms of diabetes mellitus (weight loss, fatigue, polyuria, polydipsia, vision changes)
* Patients with new diagnosis of stage I-III endometrial cancer
* Completed surgery with TH/BSO with no gross residual disease
* Recommended to undergo curative intent adjuvant chemotherapy at MSK with carboplatin and paclitaxel with or without intravaginal radiation OR cisplatin and concurrent radiation followed by carboplatin and paclitaxel. Patients may consent prior to and up to 3 weeks after the first cycle of chemotherapy.
* Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, carcinosarcoma, undifferentiated carcinoma/de-differentiated, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), and mucinous adenocarcinoma.
* Patient has adequate organ function, as defined by the following laboratory values:
1. Creatinine clearance (per Cockcroft-Gault formula) ≥30 mL/min
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN.
3. Total serum bilirubin ≤ 1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.
* Insurance approval for tirzepatide or semaglutide (alternative) or willingness to pay out-of-pocket for tirzepatide or semaglutide (alternative) for duration of study period
* Patients must be capable and willing to learn how to self-inject study drug, as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject study drug; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject study drug) and administer study drug injection (or receive an injection from a trained individual if visually impaired or with physical limitations)
* Not pregnant and not nursing
* English speaking or a family member or caregiver who speaks English and is able to assist with smart phone or tablet based Keenoa app or paper dietary recall handout (if no access to smart phone or tablet).

* Known Type 1 diabetes
* Known GAD, Islet Cell, or Zn Transporter 8 antibodies
* History of gastroparesis
* High risk for aspiration
* Active or history of chronic or acute pancreatitis
* History of elevated calcitonin
* Personal or family history of Medullary Thyroid Carcinoma with Multiple Endocrine Neoplasia-2 syndrome
* Patients with a prior surgical, endoscopic, and/or device-based therapy (for example, mucosal ablation, gastric artery embolization, intragastric balloon and duodenojejunal bypass sleeve) for obesity within the past two years
* Patients with removal of device-based therapy for obesity within the last 6 months
* Current GIP/GLP-1 or GLP-1 receptor agonist use or prior intolerance of GIP/GLP-1 or GLP-1 receptor agonist
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Known intolerance to study drug(s) or any of the excipients.

Contacts and Locations

Study Contact

Angela Green, MD

CONTACT

646-888-6792

greena@mskcc.org

Lubaina Presswala, DO

CONTACT

646-608-2914

Principal Investigator

Angela Green, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Commack

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Angela Green, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-19

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-12-19

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

tirzepatide
semaglutide
dual GIP/GLP-1 receptor
obesity
overweight
diabetes
stage I-III endometrial cancer

Additional Relevant MeSH Terms

Endometrial Cancer