A Phase II, Multicentre, Randomized Controlled Study Evaluating The Quality Of Life In Patients With Inoperable Malignant Bowel Obstruction Treated With Lanreotide Autogel 120 mg in Combination With Standard Care vs. Standard Care Alone (QOL IN IMBO STUDY)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 43
- 试验地点
- 13
- 主要终点
- Least Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)
研究概览
简要总结
The primary objective of the study is to evaluate the impact on quality of life of Lanreotide Autogel 120 mg in combination with standard care, in comparison to the standard care alone, in subjects affected by inoperable malignant bowel obstruction.
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
- 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
- •Subjects must demonstrate willingness to participate in the study and to be compliant with any protocol procedure.
- •Provision of written informed consent prior to any study related procedure.
- •Diagnosis of an inoperable malignant bowel obstruction, confirmed by appropriate imaging report.
- •In case of peritoneal carcinomatosis, diagnostic confirmation by CT or MRI scan.
- •Confirmed as inoperable after medical advice.
- •Patient with a nasogastric tube or presenting with 3 or more episodes of vomiting every day in the last consecutive 48 hours.
- •Patient life expectancy must be more than 14 days.
排除标准
- •Has operable obstruction or any sub-obstruction.
- •Has bowel obstruction due to a non-malignant cause; (hypokaliaemia, drug side-effects, renal insufficiency, etc).
- •Has signs of bowel perforation.
- •Has prior treatment with somatostatin or any analogue within the previous 60 days.
- •Has a known hypersensitivity to any of the study treatments or related compounds.
- •Is likely to require treatment during the study with somatostatin or any analogue other than the study treatment.
- •Is at risk of pregnancy or lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral or double barrier contraception. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
- •Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- •Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
研究组 & 干预措施
Standard care and Lanreotide Autogel
Standard care according to site clinical practice and Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration.
干预措施: lanreotide (Autogel formulation) (Drug)
结局指标
主要结局
Least Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)
时间窗: Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.
Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. AUC is area under the line which joins the points defined by plotting ESAS total score on vertical axis and time values on horizontal axis, computed using trapezoidal rule. Primary endpoint was analysed using the FAS. LS mean AUC of ESAS total scores during first 7 days is presented.
次要结局
- Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population(Baseline (Day 1, before randomisation) and Days 7, 14 and 28.)
- Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population(Baseline (Day 1, before randomisation) and Days 7, 14 and 28.)
- Mean Daily NGT Secretion Volume, in Patients With a NGT(Baseline (Day 1, before randomisation) and Days 7, 14 and 28.)
- Mean Change From Baseline in ESAS Total Score; FAS(Baseline (Day 1, before randomisation) and Days 7, 14 and 28.)
- Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population(Baseline (Day 1, before randomisation) and Days 7, 14 and 28.)
- Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population(Baseline (Day 1, before randomisation) and Days 7, 14 and 28.)
- Mean Change From Baseline in ESAS Total Score; ITT Population(Baseline (Day 1, before randomisation) and Days 7, 14 and 28.)
- Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT(From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.)
- Assessment of Passage of Stools; ITT Population(From Baseline (Day 1, before randomisation) to Day 28.)