Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel obstruction
| Autor: | Michael Findlay, Ryash Vather, Jackie Robinson, Cindy Lee, Ian P. Bissett, Briar McLeod, Anne O'Callaghan |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
education.field_of_study Palliative care Symptom management business.industry Population Palliative Care Phases of clinical research General Medicine medicine.disease Placebo Surgery Bowel obstruction medicine Feasibility Studies Humans In patient education business Intestinal Obstruction Diatrizoate Meglumine |
| Zdroj: | The American journal of hospicepalliative care. 30(8) |
| ISSN: | 1938-2715 |
| Popis: | Background: Malignant bowel obstruction (MBO) is common in patients with advanced cancer. Aim: To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO. Methods: Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo. Results: Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment). Conclusions: It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|