NCT01419587终止不适用
A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Non-small Cell Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Frequency of Adverse Events (Safety)
研究概览
简要总结
This study investigates if using a very low carbohydrate diet during combined chemotherapy and radiation therapy is safe and if it can be tolerated by lung cancer patients.
详细描述
Standard treatment for lung cancer includes chemotherapy concurrent with radiation therapy (chemoradiation).
This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for lung cancer. Specifically, pre-clinical data from mouse studies indicates a ketogenic diet increases tumor cell killing.
Participants will:
- Utilize a specialized ketogenic diet designed by bionutritional services of the clinical research unit. This diet begins 2 days before chemoradiation and continues through at least 5 weeks of chemoradiation.
- Have blood drawn for research purposes weekly to determine measurements of oxidative stress
- Have urine collected sporadically through the study to determine measurements of oxidative stress
- Keep a diary of concomitant medications, side effects, and blood sugars
- Have follow-up to monitor for outcomes and overall survival
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
- •Histologically or cytologically documented NSCLC.
- •Candidate for primary chemoradiation as decided by both medical and radiation oncology.
- •Cancer should be staged via AJCC as IIIA or IIIB.
- •Stage IV patients are considered provided they have a single non-CNS metastasis (that is amenable to treatment with radiation therapy).
- •Age ≥ 18 years
- •ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
- •Hypertensive medication should be initiated or increased for optimal blood pressure control according to standard public health guidelines prior to starting the ketogenic diet.
- •Patients must have normal organ and marrow function as defined below:
- •leukocytes ≥ 3,000/mm3
- •absolute neutrophil count ≥ 1,500/mm3
- •platelets ≥ 100,000/mm3
- •total bilirubin < 1.5 mg/dl
- •Hgb A1C < or = to 8%
- •AST(SGOT) < or = to 2 X institutional upper limit of normal
- •creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- •Not pregnant. Women of child-bearing 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 participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Life expectancy of 3 or less months.
- •Prior thoracic radiotherapy.
- •Prior therapy, with the intent to treat, the current diagnosis of lung cancer.
- •Known G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- •Systemic corticosteroids for any reason (inhaled corticosteroids are allowed).
- •Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable).
- •Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%).
- •Diabetes is not exclusionary provided the patient is not maintained with either oral medications or insulin.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by study team members.
- •Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented.
- •Female and male patients of all ethnic groups will be eligible for treatment in these protocols.
结局指标
主要结局
Frequency of Adverse Events (Safety)
时间窗: Weekly for 8 weeks
Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
次要结局
- Oxidative stress parameters(Weeks 1, 2, 3, 4, 5, and 6 of treatment and at 1 month follow-up)
- Ketone levels(Daily during treatment for 6 weeks)
- Blood glucose levels(Daily during treatment for 6 weeks)
- Progression Free Survival (months)(Every 12 months for 60 months)
研究者
Bryan Allen
Assistant Professor
University of Iowa
研究点 (2)
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