NCT04691960进行中（未招募）2 期
A Pilot Study of Ketogenic Diet and Metformin in Glioblastoma: Feasibility and Metabolic Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Ability to achieve and maintain ketosis
研究概览
简要总结
This clinical trial is for men and women with high-grade gliomas. Glucose (sugar) is thought to be a contributor to tumor growth. The ketogenic diet (a high fat, low carbohydrate diet) and metformin (a drug approved by the Food and Drug Administration to treat type 2 diabetes) are both known to lower blood glucose levels. The purpose of the study is to evaluate the tolerability of a ketogenic diet in conjunction with metformin and whether maintaining and the diet with metformin will have any effect on participants. Participants will prepare their own meals with the help of a nutritionist. Participants will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed high-grade glioma (e.g. glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma or other anaplastic gliomas).
- •Patients must have an MRI performed within 21 days prior to beginning the study diet and on a fixed dose of steroids for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MR/CT is required.
- •Patients must not have been exposed to bevacizumab.
- •Patients cannot be taking insulin or other oral hypoglycemic. Must be at least 6 weeks from last oral hypoglycemic or insulin.
- •Must not have known type 1 or type 2 diabetes and expected to need either insulin and/or an oral hypoglycemic agents within the next 6 months.
- •Patients must be >18 years old.
- •Karnofsky performance status >60%.
- •Life expectancy of greater than 12 weeks.
- •Patients must have normal organ and marrow function as defined below:
- •Leukocytes >3,000/mcL
- •Absolute neutrophil count >1,000/mcL
- •Platelets >100,000/mcL
- •Total bilirubin <2.0 X institutional upper limit of normal (unless known to have Gilbert's Disease)
- •AST (SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- •Serum Glucose: < 200 mg/dL
- •Creatinine < 1.5 mg/dL (for males), < 1.4 mg/dL (for females), or within normal lab limits OR
- •Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Patients must not have any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy
- •Patients having undergone recent resection or progressive tumor will be eligible as long as all of the following conditions apply:
- •They have recovered from the effects of surgery.
- •On a steroid dosage that has been stable for at least 5 days.
- •Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease postoperatively, a MRI should be done:
- •No later than 96 hours in the immediate post-operative period or
- •At least 4 weeks post-operatively, and
- •Within 14 days of registration, and
- •If the 96-hour scan is more than 21 days before registration, the scan needs to be repeated. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required on a stable steroid dosage for at least 5 days.
- •Patients must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who are receiving any other investigational agents.
- •Patients who have had prior therapy with bevacizumab and/or other VEGF inhibitors.
- •Patients who are taking insulin or other oral hypoglycemic. Must be at least 6 weeks from last oral hypoglycemic or insulin.
- •History of allergic reactions attributed to metformin.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes requiring oral hypoglycemic drugs and/or insulin, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients known to have a malignancy that has required treatment in the last 12 months and/or is expected to require treatment in the next 12 months (except nonmelanoma skin cancer or carcinoma in-situ in the cervix).
- •The effects of a Ketogenic diet or metformin on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •Patients with current alcoholism.
研究组 & 干预措施
Ketogenic Diet
Experimental
干预措施: Ketogenic Diet (Other)
Ketogenic Diet
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
Ability to achieve and maintain ketosis
时间窗: Through study completion (an average of 8 months)
Proportion of patients who can obtain and maintain a ketogenic state (of 1.5 mmol/L or 27.0 mg/dL)
Tolerability of metformin
时间窗: Through study completion (an average of 8 months)
Proportion of patients who can tolerate Metformin in the setting of the ketogenic diet (as assessed by standard CTC criteria)
次要结局
未报告次要终点
研究者
研究点 (2)
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