Back to resultsQuality of Life in Patients With Inoperable Malignant Bowel Obstruction (QoL in IMBO)
Primary Purpose
Intestinal Obstruction
Status
Terminated
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
lanreotide (Autogel formulation)
Sponsored by
About this trial
This is an interventional supportive care trial for Intestinal 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.
Sites / Locations
- Ospedale Sacro Cuore di Gesù, U.O.C. Oncologia Medica
- Ospedali riuniti Ancona- Dipartimento Medicina Interna - Clinica Oncologica
- Centro di Riferimento Oncologico - di Aviano, Dip. di Oncologia Chirurgica- S.O.C. di Chirurgia Oncologica Generale
- Istituto Tumori "Giovanni Paolo II"- Istituto di Ricovero e Cura a Carattere Scientifico, U.O.C. DI ONCOLOGIA MEDICA
- Ospedale Sacro Cuore di Gesù - Fatebenefratelli
- Hospice Convento delle Oblate
- Azienda Sanitaria Locale n ° 5 "Spezzino" Ospedale Felettino - Oncologia Via del Forno 4
- I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (I.R.S.T.) srl
- Ospedale San Raffaele IRCCS, Ginecologia oncologica
- Fondazione IRCCS Istituto Nazionale dei Tumori - Struttura Complessa di Cure Palliative, Terapia del Dolore e Riabilitazione
- Azienda Ospedaliero - Polo Universitario "Luigi Sacco"
- A.R.N.A.S. P.O. Civico Benfratelli - Oncologia Medica
- Azienda Ospedaliera Regionale San Carlo- Oncologia Medica
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Standard care and Lanreotide Autogel
Standard care
Arm Description
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.
Standard care according to site clinical practice.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean Change From Baseline in ESAS Total Score; 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.
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.
Mean Change From Baseline in ESAS Total Score; ITT Population
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.
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population
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.
Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population
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.
Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population
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.
Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT
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.
Mean Daily NGT Secretion Volume, in Patients With a NGT
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.
Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population
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.
Assessment of Passage of Stools; ITT Population
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02365584
Brief Title
Quality of Life in Patients With Inoperable Malignant Bowel Obstruction
Acronym
QoL in IMBO
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early due to insufficient recruitment.
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 16, 2018 (Actual)
Study Completion Date
January 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Obstruction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care and Lanreotide Autogel
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care according to site clinical practice.
Intervention Type
Drug
Intervention Name(s)
lanreotide (Autogel formulation)
Intervention Description
Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration.
Primary Outcome Measure Information:
Title
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)
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.
Time Frame
Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in ESAS Total Score; FAS
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.
Time Frame
Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Title
Mean Change From Baseline in ESAS Total Score; ITT Population
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.
Time Frame
Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Title
Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population
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.
Time Frame
Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Title
Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population
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.
Time Frame
Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Title
Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population
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.
Time Frame
Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Title
Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT
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.
Time Frame
From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.
Title
Mean Daily NGT Secretion Volume, in Patients With a NGT
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.
Time Frame
Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Title
Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population
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.
Time Frame
Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Title
Assessment of Passage of Stools; ITT Population
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.
Time Frame
From Baseline (Day 1, before randomisation) to Day 28.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale Sacro Cuore di Gesù, U.O.C. Oncologia Medica
City
Gallipoli
State/Province
Lecce
ZIP/Postal Code
73014
Country
Italy
Facility Name
Ospedali riuniti Ancona- Dipartimento Medicina Interna - Clinica Oncologica
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Centro di Riferimento Oncologico - di Aviano, Dip. di Oncologia Chirurgica- S.O.C. di Chirurgia Oncologica Generale
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Istituto Tumori "Giovanni Paolo II"- Istituto di Ricovero e Cura a Carattere Scientifico, U.O.C. DI ONCOLOGIA MEDICA
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale Sacro Cuore di Gesù - Fatebenefratelli
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Hospice Convento delle Oblate
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Sanitaria Locale n ° 5 "Spezzino" Ospedale Felettino - Oncologia Via del Forno 4
City
La Spezia
ZIP/Postal Code
19124
Country
Italy
Facility Name
I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (I.R.S.T.) srl
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Ospedale San Raffaele IRCCS, Ginecologia oncologica
City
Milano
ZIP/Postal Code
20100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori - Struttura Complessa di Cure Palliative, Terapia del Dolore e Riabilitazione
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliero - Polo Universitario "Luigi Sacco"
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
A.R.N.A.S. P.O. Civico Benfratelli - Oncologia Medica
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Regionale San Carlo- Oncologia Medica
City
Potenza
ZIP/Postal Code
85100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Quality of Life in Patients With Inoperable Malignant Bowel Obstruction
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