An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Resolution of OIC
研究概览
简要总结
The aim of the project is to investigate OIC in a real world / diverse group of patients with cancer.
The objectives of the project are to determine: a) efficacy of a treatment algorithm to manage OIC; b) efficacy of conventional laxatives to manage OIC; c) efficacy of PAMORAs / other interventions to manage OIC.
详细描述
StOIC-2 is an observational study of routine clinical practice, and will involve four assessments over a period of 28 days (3 face to face; 1 telephone). Participants for StOIC 2 study will be identified from StOIC 1 study (CancerTrials.gov registry reference number - NCT04350112). Visit 1 for StOIC 2 study will correspond to the assessment for StOIC 1 study.
Patients will be managed according to a treatment algorithm (see below), which is based on a review of the evidence (and which is the basis of the Multinational Association for Supportive Care in Cancer (MASCC) guideline on the treatment of constipation in patients with advanced cancer). The decision to change treatment is based on efficacy / lack of efficacy (as determined by the Bowel Function Index (see below), or the development of adverse effects.
Step 1: Conventional Laxatives
- Choice of laxatives at the discretion of the clinical team
- Combination of softener and stimulant laxative
- Laxatives to be prescribed on a regular basis
Step 2: Peripherally acting mu opioid receptor antagonist (PAMORA)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •As per StOIC 1: age > 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week
- •Diagnosis of OIC as defined by the Rome IV criteria (Lacy et al, 2016)
- •Diagnosis of inadequately treated OIC as defined by BFI > 30
排除标准
- •As per StOIC 1: inability to give informed consent; inability yo complete questionnaire
- •Prognosis > 1 month
结局指标
主要结局
Resolution of OIC
时间窗: 28 days
BFI \< 30
次要结局
- Improvement in BFI(28 days)