NCT01975766终止不适用
A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck Cancer
Bryan Allen2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2014年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 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 patients.
详细描述
Standard treatment for head & neck cancer often includes chemotherapy concurrent with radiation therapy (chemoradiation).
This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for head & neck 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 squamous cell carcinoma of the oropharynx, larynx or hypopharynx. HPV status will not be assessed for eligibility; while HPV status may affect response to therapy, efficacy is not an outcome measure for this phase I study.
- •Candidate for primary chemoradiation as decided by an interdisciplinary team including otolaryngology, medical oncology, and radiation oncology.
- •Cancer should be staged via AJCC as stage II, III or IVa.
- •Age ≥ 18 years
- •ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
- •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 < 8%
- •AST(SGOT) < 2 X institutional upper limit of normal
- •creatinine < 1.5 X institutional upper limit of normal OR calculated 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 neck and/or upper thoracic radiotherapy that would cause an overlap of treatment fields.
- •Prior therapy to the head and neck, with the intent to treat, the current diagnosis of head & neck cancer.
- •Known / established G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- •Chronic system corticosteroids for any reason (inhaled corticosteroids are allowed). Pre-medication for chemotherapy is acceptable.
- •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.
研究组 & 干预措施
Ketogenic diet
Experimental
Ketogenic diet designed to sustain ketone levels through treatment.
干预措施: External beam radiation therapy (Device)
Ketogenic diet
Experimental
Ketogenic diet designed to sustain ketone levels through treatment.
干预措施: Ketogenic diet (Dietary Supplement)
结局指标
主要结局
Frequency of adverse events (safety)
时间窗: weekly for 5 weeks
Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
次要结局
- Blood glucose levels(daily during treatment for 5 weeks)
- Ketone levels(Daily during treatment for 5 weeks)
- Oxidative stress parameters(Weeks 1, 2, 3, 4, and 5 of treatment and at 1 month follow-up)
- Progression Free Survival (months)(Every 12 months for 60 months)
研究者
Bryan Allen
Assistant Professor, Department of Radiation Oncology
University of Iowa
研究点 (2)
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