Clinical trial NCT02365584: Quality of Life in Patients With Inoperable Malignant Bowel Obstruction
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Intestinal Obstruction
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Mean Change From Baseline in ESAS Total Score; FAS
timeFrame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
measure: Mean Change From Baseline in ESAS Total Score; ITT Population
timeFrame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
measure: Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population
timeFrame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
measure: Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population
timeFrame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
measure: Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population
timeFrame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
measure: Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT
timeFrame: From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.
measure: Mean Daily NGT Secretion Volume, in Patients With a NGT
timeFrame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
measure: Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population
timeFrame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
measure: Assessment of Passage of Stools; ITT Population
timeFrame: From Baseline (Day 1, before randomisation) to Day 28.
Other outcomes:
Locations:
city: Gallipoli
country: Italy
facility: Ospedale Sacro Cuore di Gesù, U.O.C. Oncologia Medica
state: Lecce
city: Ancona
country: Italy
facility: Ospedali riuniti Ancona- Dipartimento Medicina Interna - Clinica Oncologica
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - di Aviano, Dip. di Oncologia Chirurgica- S.O.C. di Chirurgia Oncologica Generale
city: Bari
country: Italy
facility: Istituto Tumori "Giovanni Paolo II"- Istituto di Ricovero e Cura a Carattere Scientifico, U.O.C. DI ONCOLOGIA MEDICA
city: Benevento
country: Italy
facility: Ospedale Sacro Cuore di Gesù - Fatebenefratelli
city: Firenze
country: Italy
facility: Hospice Convento delle Oblate
city: La Spezia
country: Italy
facility: Azienda Sanitaria Locale n ° 5 "Spezzino" Ospedale Felettino - Oncologia Via del Forno 4
city: Meldola
country: Italy
facility: I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (I.R.S.T.) srl
city: Milano
country: Italy
facility: Ospedale San Raffaele IRCCS, Ginecologia oncologica
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori - Struttura Complessa di Cure Palliative, Terapia del Dolore e Riabilitazione
city: Milano
country: Italy
facility: Azienda Ospedaliero - Polo Universitario "Luigi Sacco"
city: Palermo
country: Italy
facility: A.R.N.A.S. P.O. Civico Benfratelli - Oncologia Medica
city: Potenza
country: Italy
facility: Azienda Ospedaliera Regionale San Carlo- Oncologia Medica
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: