A Phase I/II Study of Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Phase I - Maximum Tolerated Dose (MTD)
研究概览
简要总结
The purpose of this study is to:
- Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn.
- Determine if sodium bicarbonate can reduce cancer-related pain.
详细描述
Single institution Phase I/II study of sodium bicarbonate in combination with standard medical management for patients with moderate to severe tumor related pain.
Patients with metastatic solid malignancies and patients with hematologic malignancies with moderate to severe tumor related pain on a stable opioid regimen will be the subjects of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 metastatic or unresectable solid malignancy or hematologic malignancy (multiple myeloma or lymphoma) and must have moderate to severe tumor related pain visual assessment scale (VAS)>4) on a stable or no opioid regimen (at least 3 days of an opiate regimen). VAS score should be greater than 4 at screening to be eligible.
- •No planned palliative surgery, palliative radiotherapy for at least 4 weeks. However prior radiotherapy, and surgery is allowed and not limited to the number of procedures and courses. Concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) is allowed.
- •No evidence of neurologic or psychiatric compromise which in the opinion of the investigator will interfere with completion of study assessments
- •Age greater than 18 years and able to understand and sign the informed consent document
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status less than
- •A female patient and a male patient's female partner, of childbearing potential, must agree to use 2 adequate barrier methods of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting from Visit 1, while receiving protocol-specified medication, and for 1 month after stopping the medication.
排除标准
- •Patients with neuropathy and/or neuropathic pain as the only pain syndrome are not eligible.
- •Patients with only chronic non-malignant pain are not eligible.
- •Patients with renal insufficiency (creatinine > 2.5mg/dL) are excluded.
- •Patients with history of congestive heart failure or pulmonary artery hypertension will be excluded.
- •Patients with uncontrolled hypertension (systolic pressure >160, diastolic pressure >100) despite maximal antihypertensive therapy
- •Patients unable to ingest sodium bicarbonate capsules (such as patients with dysphagia or severe nausea)
- •Patients with ECOG performance status 3 or higher
- •Patients with acute leukemia, myelodysplastic syndrome, and chronic myeloid leukemia are not eligible.
- •Pregnant or lactating patients are not eligible.
- •Patients with known allergy to sodium bicarbonate or patients with preexisting renal or acid base disorders for which sodium bicarbonate is contraindicated (such as metabolic alkalosis, severe congestive heart failure, hypernatremia, and hypocalcemia (see above))
- •Patients with severe ongoing infections which places the patients at increased risks from therapy in the opinion of the investigator
- •Patients receiving concomitant chemotherapy with agents indicated in protocol guidelines (Tables 10 and 11B, Appendix IV) or target therapy intended to prolong life within 2 weeks of starting the study drug
- •Patients receiving experimental therapy within 2 weeks of starting study treatment
研究组 & 干预措施
Sodium Bicarbonate Treatment
A 3+3 design for Phase I component and a two staged design for Phase II were to be used. Treatment: Sodium Bicarbonate Capsules (900 mg).
干预措施: Sodium Bicarbonate (Drug)
结局指标
主要结局
Phase I - Maximum Tolerated Dose (MTD)
时间窗: 4 weeks per participant
To evaluate the safety (Phase I) of oral Sodium bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain. To determine the maximum tolerated dose (MTD) of oral sodium bicarbonate capsules for patients with tumor related moderate to severe pain.
Phase II - Percent of Participants With Desired Response
时间窗: 4 weeks per participant
Evaluate the efficacy (Phase II) of oral Sodium Bicarbonate capsules as an adjuvant pain reliever in patients with tumor related moderate to severe pain. Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale at 4 weeks compared to baseline without a corresponding increase in opioid regimen. The response rate with 95% Clopper-Pearson confidence interval will be reported.
次要结局
- Pain Measurement Ranking(4 weeks per participant)
- Quality of Life (QOL)(4 weeks per participant)