Quality of Life in Patients With Inoperable Malignant Bowel Obstruction (NCT02365584) | Clinical Trial Compass
TerminatedPhase 2
Quality of Life in Patients With Inoperable Malignant Bowel Obstruction
Stopped: The study was terminated early due to insufficient recruitment.
Italy43 participantsStarted 2015-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 thre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.