Chronic Oral Bicarbonate Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adherence measured by the time to evidence of adherence failure
研究概览
简要总结
This pilot phase I trial studies the safety of long-term use of sodium bicarbonate in patients with cancer. Sodium bicarbonate may neutralize tumor acidity and as a result may inhibit the spread of the tumor to other parts of the body (metastases) and improve survival.
详细描述
PRIMARY OBJECTIVES:
I. Determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is feasible and well tolerated as measured by the proportion of subjects with first evidence of adherence failure.
SECONDARY OBJECTIVES:
I. Determine if the dose concentration of 0.5 g/kg/day sodium bicarbonate is safe for long term consumption (90 days) as measured by blood pressure, resting pulse rate, and basic metabolic panels to assess metabolic alkalosis.
OUTLINE:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any cancer patient enrolled in the study must have a written approval from their oncologist that a notation will be made in the patient's chart for their study participation
- •Subject without known cognitive impairment, central nervous system (CNS) metastasis, overt psychosis, major depression, or delirium as noted in the oncology medical record
- •Subject with a Karnofsky performance status scale of 80% or greater at time of consent
- •Subject has completed initial adjuvant therapy and is not currently receiving or waiting to receive chemotherapy during the next 120 days
- •Breast cancer subjects may be enrolled if they are receiving hormonal blockade therapy
- •Subject is not enrolled in any other clinical trials
- •Subject has a valid working phone number to be contacted with during the study
- •Subject must be willing to provide urine specimen for pH measurements during scheduled clinical visits
- •Subject must be willing to provide a 3 mL blood sample for metabolic panels during scheduled clinical visits
- •Subject does not have uncontrolled hypertension (systolic pressure > 140, diastolic pressure > 90) despite maximal anti-hypertensive therapy
- •Subject has healthy renal function: creatinine clearance: 88-128 mL/min; glomerular filtration rate (GFR): > 90 mL/min/1.7m^2 based on standard care results no older than 2 weeks; if no data exist, the subject will need to consent to a blood draw for a basic metabolic panel (which measures creatinine) for verification
- •Subject must be informed of the investigational nature of this study and must sign and written informed consent in accordance with institutional and federal guidelines
- •Subject is not pregnant or breastfeeding at time of consent; a pregnancy test will be conducted from urine sample on day of consent in premenopausal women
- •Subject agrees to use medically approved contraception (ie. condoms, oral contraceptive) if premenopausal
排除标准
- 未提供
研究组 & 干预措施
Sodium Bicarbonate
Dose concentration of 0.5 g/kg/day
干预措施: Sodium Bicarbonate (Drug)
结局指标
主要结局
Adherence measured by the time to evidence of adherence failure
时间窗: 120 days
次要结局
- Assessment of Metabolic Alkalosis by measurement of blood pH from basic metabolic panels(120 days)