IMBO Pilot study
ACTRN12621001403820
Treatment
Phase 2
Other,SPHERE
Prof Meera Agar
The aim of this study is to determine whether it is feasible to conduct a study of crushed oral dexamethasone, at a dose of at least 8 mg daily, either with or without daily crushed oral famotidine in the management of inoperable bowel obstruction. Who is it for? You may be eligible for this study if you are aged 18 years or older, have advanced cancer, and have a clinically confirmed inoperable bowel obstruction at any level with vomiting that requires a hospital admission or a change in clinic .... Read more
• Advanced cancer; • Clinically confirmed bowel obstruction at any level with vomiting that precipitates a hospital admission or change in clinical care; • Deemed by two consultant level medical practitioners that this person has a bowel obstruction (partial or complete) for which immediate surgery is not indicated; • Disease-modifying therapy (surgery, chemotherapy, radiotherapy, hormone therapy; biological/targeted therapies) is deemed by relevant practitioners unlikely to change the bowel obs .... Read more
• Previous adverse reaction to any of the study medications; • Calculated creatinine clearance <10 mL / min using the Modification of Diet in Renal Disease Study (MDRD) formula; • Venting or feeding gastrostomy or jejunostomy; • Participant has a NGT that, in the investigator’s opinion, cannot be clamped for the duration of treatment; and • Oral food intake that cannot be reduced to clear fluids
No
Sample Size 4
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Bowel Obstruction , Bowel cancer , Malignant Bowel Obstruction
Condition code Cancer
Intervention code Treatment: Drugs
Crushed Famotidine tablet for oral consumption, 40 mg every 24 hours for 5 days, within 24 hours of baseline assessments, administered in a thick fluid such as yoghurt or apple puree. Administered by nursing staff, witnessed and recorded as administered within the medication record. The medical record is considered the record of adherence. Crushed Dexamethasone for oral consumption, 8mg once per day in the morning for 5 days and to be commenced before midday on the first day or the next morning .... Read more
Control group Placebo
Crushed oral placebo for oral consumption every 24 hours for a total of 5 days, within 24 hours of baseline assessments. Administered by nursing staff, witnessed and recorded as administered within the medication record. The medical record is considered the record of adherence. The placebo contains PROSOLV® EASYTab SP which contains: Microcrystalline Cellulose, Colloidal Silicon Dioxide, Sodium Starch Glycolate and Sodium Stearyl Fumarate. Crushed Dexamethasone for oral consumption, 8mg once per .... Read more
Outcome: The primary outcome is whether this study is feasible to extend to a fully powered phase III clinical trial. Feasibility is defined as: 1. An average of one participant identified per site every eight weeks using recruitment tracking data bases; 2. One participant recruited per site every 12 weeks using recruitment racking databases; and 3. Collect data for >80% of people randomised, to the primary endpoint of 120 hours or study exit assessed by reviewing the data ent .... Read more