Intestinal ObstructionPhase 2QoL in IMBONCT02365584
Quality of Life in Patients With Inoperable Malignant Bowel Obstruction
A Phase 2 study testing lanreotide (Autogel formulation) in people with Intestinal Obstruction, run by Ipsen at 13 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Obstruction
- What is being tested?
- lanreotide (Autogel formulation)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 13 sitesItaly
- Study dates
- Jan 2015to 16 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Ospedali riuniti Ancona- Dipartimento Medicina Interna - Clinica Oncologica
Ancona, 60020
Centro di Riferimento Oncologico - di Aviano, Dip. di Oncologia Chirurgica- S.O.C. di Chirurgia Oncologica Generale
Aviano, 33081
Istituto Tumori "Giovanni Paolo II"- Istituto di Ricovero e Cura a Carattere Scientifico, U.O.C. DI ONCOLOGIA MEDICA
Bari, 70124
Ospedale Sacro Cuore di Gesù - Fatebenefratelli
Benevento, 82100
Hospice Convento delle Oblate
Florence, 50139
Ospedale Sacro Cuore di Gesù, U.O.C. Oncologia Medica
Gallipoli, Lecce, 73014
Azienda Sanitaria Locale n ° 5 "Spezzino" Ospedale Felettino - Oncologia Via del Forno 4
La Spezia, 19124
I.R.C.C.S. Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (I.R.S.T.) srl
Meldola, 47014
Ospedale San Raffaele IRCCS, Ginecologia oncologica
Milan, 20100
Fondazione IRCCS Istituto Nazionale dei Tumori - Struttura Complessa di Cure Palliative, Terapia del Dolore e Riabilitazione
Milan, 20133
Azienda Ospedaliero - Polo Universitario "Luigi Sacco"
Milan, 20157
A.R.N.A.S. P.O. Civico Benfratelli - Oncologia Medica
Palermo, 90127
Azienda Ospedaliera Regionale San Carlo- Oncologia Medica
Potenza, 85100
About this study
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)
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
- Being tested
- lanreotide (Autogel formulation)
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: lanreotide (Autogel formulation) |
| Standard care | No intervention | Standard care according to site clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
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.
Measured: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
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.
Measured: From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.
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.
Measured: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
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.
Measured: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
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.
Measured: From Baseline (Day 1, before randomisation) to Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Why it stopped: The study was terminated early due to insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intestinal ObstructionStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365584
- Sponsor's protocol ID
- A-93-52030-279
- Other IDs
- 2013-003176-12
- Acronym
- QoL in IMBO
- Status last verified
- Nov 2019
- First submitted
- 29 Jan 2015
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02365584
- Acronym / sponsor ID
- QoL in IMBO / A-93-52030-279
- Conditions
- Intestinal Obstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to insufficient recruitment.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care and Lanreotide Autogel | Experimental | Drug: lanreotide (Autogel formulation)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 | No intervention | –Standard care according to site clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lanreotide (Autogel formulation)Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration. | Drug | Standard care and Lanreotide Autogel |
Primary outcome
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.
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.
9 secondary outcomes
Mean Change From Baseline in ESAS Total Score; FAS
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
Mean Change From Baseline in ESAS Total Score; ITT Population
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
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.
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.
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.
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.
Mean Daily NGT Secretion Volume, in Patients With a NGT
Time frame: Baseline (Day 1, before randomisation) and Days 7, 14 and 28.
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.
Assessment of Passage of Stools; ITT Population
Time frame: From Baseline (Day 1, before randomisation) to Day 28.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lanreotide (Autogel formulation) in people with Intestinal Obstruction, run by Ipsen at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.