Pilot Study of Metformin in Head and Neck Cancer and Its Effect on Proinflammatory Cytokines and Exosomes Implicated in Acute and Chronic Toxicity
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Cytokine/Chemokine Profile
研究概览
简要总结
This pilot clinical trial studies how well metformin hydrochloride works in affecting cytokines and exosomes in patients with head and neck cancer. Metformin hydrochloride may reduce the metabolic activity of cancer cells and of surrounding supportive tissues.
详细描述
PRIMARY OBJECTIVES:
I. To assess the capacity of metformin hydrochloride (metformin) to alter the cytokine and exosome profiles.
II. To assess the capacity of metformin to mitigate known side effects of external beam radiation therapy including inflammation, mucositis, dysphagia, xerostomia, and fatigue.
SECONDARY OBJECTIVES:
I. Assess safety and tolerability of metformin treatment in subjects undergoing external beam radiation treatment for head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of head and neck cancer biopsy proven, and who are candidates for radiation therapy
- •All subjects must be able to comprehend and sign a written informed consent document.
排除标准
- •Subjects who are pregnant or may become pregnant during metformin administration; pregnancy testing will be done in conjunction with preradiation protocols
- •Subjects on metformin for any reason during the preceding 4 weeks
- •Diabetic subjects are eligible if they are not taking metformin or insulin
- •Subjects who have received iodinated contrast dye must wait 12 hours prior to starting Metformin. If a CT scan with contrast is scheduled after screening and consent, the metformin cannot be taken until after the CT with contrast has been completed and they have waited 12 hours.
- •Patients with plasma creatinine level greater than 1.3 mg/dL
- •Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
- •Patients with history of congestive heart failure
- •Patients with myocardial ischemia or peripheral muscle ischemia
- •Patients with sepsis or severe infection
- •Patients with history of lung disease currently requiring any supplemental oxygen treatment
- •Patients scheduled for radiation less than 6 days from enrollment
- •Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
- •Patients with a current history (in the past 30 days) of heaving drinking which is defined in accordance with CDC definition as more than 8 drinks per week for women and more than 15 drinks per week for men. A standard drink contains .6 ounces of pure alcohol. Generally, this amount of pure alcohol is found in 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey). While on study, patients should limit their alcohol consumption to no more than 8 drinks per week for women and no more than 15 drinks per week for men. Patients who feel they cannot comply with this recommendation are not eligible".
- •All medications are permitted except those that are contraindicated with metformin under current Food and Drug Administration (FDA) recommendations
研究组 & 干预措施
Arm I (EBRT, metformin hydrochloride)
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
干预措施: External Beam Radiation Therapy (Radiation)
Arm I (EBRT, metformin hydrochloride)
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive metformin hydrochloride PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
干预措施: Metformin Hydrochloride (Drug)
Arm II (EBRT, placebo)
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
干预措施: External Beam Radiation Therapy (Radiation)
Arm II (EBRT, placebo)
Patients undergo External Beam Radiation Therapy (EBRT). Beginning 1 week prior to start of EBRT, patients receive placebo PO QD for 3 days and BID thereafter until 2 weeks after completion of EBRT.
干预措施: Placebo (Other)
结局指标
主要结局
Cytokine/Chemokine Profile
时间窗: Up to 1 year
Mixed effects linear regression will be used to model longitudinal measurements of each cytokine.
次要结局
- Mucositis Assessed Using WHO Classification(Up to 1 year)
- Objective Response Rate(Up to 2 years)
- Exosome Profile(Up to 1 year)
- Incidence of Toxicities(Up to 2 years)