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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

Short name QoL in IMBO

NCTNCT02365584 (opens ClinicalTrials.gov in a new tab)Other idA-93-52030-279Other id2013-003176-12
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
43 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Italy

Start
Jan 2015
Primary completion
16 Jan 2018
Completion
16 Jan 2018
First posted
19 Feb 2015 (estimated)
Last update posted
22 Nov 2019
Conditions
Intestinal Obstruction

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 2

    QoL in IMBO

    NCT02365584

    Jan 2015 to 16 Jan 2018

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • lanreotide (Autogel formulation)Drug

Arms2

  • Experimental

    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.

  • No intervention

    Standard care

    Standard care according to site clinical practice.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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)

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

    Registry description

    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.

Secondary outcomes(9)

  1. Mean Change From Baseline in ESAS Total Score; FAS

    Time frame · Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

    Registry description

    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. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the FAS; a positive change indicates a worsening condition.

  2. Mean Change From Baseline in ESAS Total Score; ITT Population

    Time frame · Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

    Registry description

    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. Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the ITT population; a positive change indicates a worsening condition.

  3. Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population

    Time frame · Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

    Registry description

    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). 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. Mean change from baseline of each individual ESAS item score at Days 7, 14 and 28 is presented; a positive change indicates a worsening condition.

  4. Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population

    Time frame · Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

    Registry description

    The KPS allows patients to be classified as to their functional impairment and was used to assess general activity. KPS scores range from 0 (dead) to 100 (normal/no disease) and are classified as 0-40 = unable to care for self; 50-70 = unable to work; 80-100 = able to work. The lower the KPS score, the worse the survival for most serious illnesses. Scores were recorded on the patient's medical file at each study visit (Days 1, 7, 14 and 28). Mean change from baseline of KPS score at Days 7, 14 and 28 is presented for the ITT population (all randomised patients); a negative change indicates a worsening condition.

  5. Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population

    Time frame · Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

    Registry description

    Abdominal pain was assessed using the VAS numeric pain distress scale which is a 100-millimetre (10-centimetre) scoring scale on which patients mark their perceived level of pain. Scores range from 0 to 100 where 0=no pain and 100=unbearable pain. Higher scores indicate a worse outcome. Scores were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline of VAS for abdominal pain at Days 7, 14 and 28 is presented for the ITT population; a positive change indicates a worsening condition.

  6. Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT

    Time frame · From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.

    Registry description

    Vomiting episodes and NGT presence were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Number of patients experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days, in patients without NGT, is presented.

  7. Mean Daily NGT Secretion Volume, in Patients With a NGT

    Time frame · Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

    Registry description

    NGT presence and related secretion volume were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean daily secretion volumes, in patients with NGT, is presented.

  8. Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population

    Time frame · Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

    Registry description

    Vomiting episodes were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline in number of daily vomiting episodes is presented for the ITT population.

  9. Assessment of Passage of Stools; ITT Population

    Time frame · From Baseline (Day 1, before randomisation) to Day 28.

    Registry description

    Passage of stools assessments (Yes/No) were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.

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)

GroupValue (Scores on a scale x time (day))Spread
Standard Care17912.4
Standard Care + Lanreotide Autogel19012.4
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Mean Change From Baseline in ESAS Total Score; FAS

GroupValue (Scores on a scale)Spread
Standard Care-5.115.7
Standard Care + Lanreotide Autogel1.918.4
Secondary outcomeMean· Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Mean Change From Baseline in ESAS Total Score; ITT Population

GroupValue (Scores on a scale)Spread
Standard Care-5.115.7
Standard Care + Lanreotide Autogel1.518.1
Secondary outcomeMean· Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population

GroupValue (Scores on a scale)Spread
Standard Care-1.83.6
Standard Care + Lanreotide Autogel0.13.4
Secondary outcomeMean· 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

GroupValue (Scores on a scale)Spread
Standard Care-2.812.3
Standard Care + Lanreotide Autogel-3.76.8
Secondary outcomeMean· 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

GroupValue (Scores on a scale)Spread
Standard Care-22.032.5
Standard Care + Lanreotide Autogel-9.630.8
Secondary outcomeCount of participants· From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.

Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT

GroupValue (Participants)
Standard Care5
Standard Care + Lanreotide Autogel4
Secondary outcomeMean· Baseline (Day 1, before randomisation) and Days 7, 14 and 28.

Mean Daily NGT Secretion Volume, in Patients With a NGT

GroupValue (millilitres)Spread
Standard Care200.0NA
Standard Care + Lanreotide Autogel700.0141.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Standard CarePatients received standard care only according to site clinical practice.2 / 212 / 215 / 21
Standard Care + Lanreotide AutogelPatients received standard care according to site clinical practice and a single administration of Lanreotide Autogel 120 mg by deep subcutaneous injection on Day 1.2 / 222 / 225 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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