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New treatment option for Endometrial Cancer
Official title A Study of a Weight Loss Intervention in People With Endometrial Cancer
ClinicalTrials.gov ID: NCT06751589
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly, being studied as a potential treatment for endometrial cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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 is defined as known history of Type 2 diabetes, HbA1c ≥ 6.5%, fasting blood glucose ≥126 mg/dL on 2 occasions, or random...
- Patients with new diagnosis of stage I-III endometrial cancer
You likely can't join if
- 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
See the full eligibility 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...
- 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 or without intravaginal radiation or external pelvic radiation. Chemotherapy regimen must include carboplatin and paclitaxel x 4-6 cycles...
- Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, carcinosarcoma, undifferentiated carcinoma/de-differentiated, clear cell adenocarcinoma...
- Patient has adequate organ function, as defined by the following laboratory values:
- Creatinine clearance (per Cockcroft-Gault formula) ≥30 mL/min Creatinine clearance (mL/min) = ((140-age)\ wt) \ 0.85 for female/(creatinine\ 72)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN.
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- Known intolerance to study drug(s) or any of the excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.