NCT06751589招募中1 期
Pilot Weight Loss Intervention With Dual GIP/GLP-1 Receptor Agonist Therapy in Patients With Endometrial Cancer and Obesity, Overweight, With or Without Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 14
- 主要终点
- percentage of patients that complete treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 or without intravaginal radiation or external pelvic radiation. Chemotherapy regimen must include carboplatin and paclitaxel x 4-6 cycles. Cisplatin may be included at the discretion of the treating physician during concurrent standard chemoradiation. Patients may consent prior to and up to 8 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:
- •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 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).
排除标准
- •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.
研究组 & 干预措施
tirzepatide
Experimental
Patients will meet with the study endocrinologist during screening and be prescribed SC tirzepatide 2.5 mg administered using a pre-filled injector once weekly for 4 weeks and then increase to 5 mg once weekly. If insurance does not cover tirzepatide, the GLP-1 agonist semaglutide (Wegovy, Ozempic) initiated at 0.25 mg weekly SC may be substituted if deemed appropriate by the study PI.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
percentage of patients that complete treatment
时间窗: 1 year
measured by the percentage of patients that complete at least 70% of weekly doses, specifically 17 out of 24 weekly doses.
次要结局
- frequency of gastrointestinal adverse events(up to 24 2weeks)
研究者
研究点 (14)
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