radiation induced diarrhoea
Conditions
Interventions
Trade Name: Somatuline Autogel Injectable 60 / 90 / 120 mg
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patient with radiation induced diarrhoea requiring daily loperamide intake (=16mg) for at least 3 consecutive days. • Administration of lanreotide 120mg at least 7 days before ending radiotherapy. • = 3 stools per 24 hours before radiotherapy • > 3 stools per 24 hours in the screening period. • Subject having provided written informed consent prior to any study related procedures • Subject of 18 years and older • Subject mentally fit for completing a diary Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea, • Has received a treatment with somatostatin analogues for any other indication within the last 6 months before study entry, • Has received a treatment with laxatives within the last week before study entry, • Suffers from IBS with alternating bowel habits and predominant constipation, • Suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn´s disease and macroscopic colitis), • Has a known intolerance to lanreotide or other somatostatin analogues, • Has abnormal baseline findings or any other medical condition(s) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the response (complete and/or partial) of lanreotide autogel 120 mg as add-on to loperamide 16 mg on stool frequency and loperamide intake in patients with radiation induced diarrhea not enough responding to loperamide 16 mg monotherapy compared to baseline.;Secondary Objective: 1. To assess the effect of the add-on of lanreotide autogel 120 mg on Quality of Life (QOL) at day 14, 28, 42 and 3 months compared to baseline. 2. To assess the timing of the first and maximal effect of lanreotide autogel 120 mg on radiation induced diarrhea. 3. To assess the effect of lanreotide autogel 120 mg on the duration of radiation induced diarrhea after ending therapy. 4. To assess any difference in response or effect on QOL of lanreotide autogel 120mg if concomitant chemotherapy is used. 5. To investigate the safety and tolerability of lanreotide autogel 120 mg.;Primary end point(s): Complete response: loperamide-intake reduction of 75% or more and = 3 stools per 24 hours. Partial response: loperamide-intake reduction of 50% up to 75% and = 3 stools per 24 hours;Timepoint(s) of evaluation of this end point: Response is assessed at day 14 (d12-14), 28 (d26-28) and 42 (d40-42) compared to baseline (d-3 to d-1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in QOL (assess using EQ-5D-5L, EORTC QLQ-C30) at Day 14/28 compared to baseline • Timing of first partial and complete response • Timing of normalization of stools (no loperamide intake and <3/stools per 24 hours) after ending of treatment if no complete response was reached during treatment • Assessing any difference in primary or secondary (point 1 to 3) effect between patients receiving concomitant chemotherapy or not receiving chemotherapy. • Incidence of all adverse events will be recorded ;Timepoint(s) of evaluation of this end point: Change in QOL (assess using EQ-5D-5L, EORTC QLQ-C30) at Day 14/28 compared to baseline • Timing of first partial and complete response • Timing of normalization of stools (no loperamide intake and <3/stools per 24 hours) after ending of treatment if no complete response was reached during treatment • Assessing any difference in primary or secondary (point 1 to 3) effect between patients receiving concomitant chemotherapy or not receiving chemotherapy throughout the trial. • Incidence of all adverse events will be recorded throughout the trial | — |
Countries
Belgium
Contacts
Public ContactDe Crop Maaike
University Hospital Ghent
Outcome results
None listed