Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

NCT02365584 | Terminated Phase 2 Results

• 2 other identifiers: A-93-52030-2792013-003176-12
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 13

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.

Conditions

Intestinal Obstruction

Outcome Measures

Primary Outcomes (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)

  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.

  Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.

Secondary Outcomes (9)

• 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 ESAS Total Score; ITT Population

  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 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.

Study Arms (2)

Standard care and Lanreotide Autogel

EXPERIMENTAL

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.

Drug: lanreotide (Autogel formulation)

Standard care

NO INTERVENTION

Standard care according to site clinical practice.

Interventions

lanreotide (Autogel formulation) DRUG

Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration.

Standard care and Lanreotide Autogel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (13)

Ospedale Sacro Cuore di Gesù, U.O.C. Oncologia Medica

Gallipoli, Lecce, 73014, Italy

Location

Ospedali riuniti Ancona- Dipartimento Medicina Interna - Clinica Oncologica

Ancona, 60020, Italy

Location

Centro di Riferimento Oncologico - di Aviano, Dip. di Oncologia Chirurgica- S.O.C. di Chirurgia Oncologica Generale

Aviano, 33081, Italy

Location

Istituto Tumori "Giovanni Paolo II"- Istituto di Ricovero e Cura a Carattere Scientifico, U.O.C. DI ONCOLOGIA MEDICA

Bari, 70124, Italy

Location

Ospedale Sacro Cuore di Gesù - Fatebenefratelli

Benevento, 82100, Italy

Location

Hospice Convento delle Oblate

Florence, 50139, Italy

Location

Azienda Sanitaria Locale n ° 5 "Spezzino" Ospedale Felettino - Oncologia Via del Forno 4

La Spezia, 19124, Italy

Location

I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (I.R.S.T.) srl

Meldola, 47014, Italy

Location

Ospedale San Raffaele IRCCS, Ginecologia oncologica

Milan, 20100, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori - Struttura Complessa di Cure Palliative, Terapia del Dolore e Riabilitazione

Milan, 20133, Italy

Location

Azienda Ospedaliero - Polo Universitario "Luigi Sacco"

Milan, 20157, Italy

Location

A.R.N.A.S. P.O. Civico Benfratelli - Oncologia Medica

Palermo, 90127, Italy

Location

Azienda Ospedaliera Regionale San Carlo- Oncologia Medica

Potenza, 85100, Italy

Location

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

The study was terminated early due to insufficient recruitment. As a consequence, the results of the analyses should be interpreted cautiously and no conclusions should be made.

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen SpA

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 19, 2015
• Study Start: January 1, 2015
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: November 22, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-11

Locations

IT (13)