Malignant Bowel Obstruction Clinical Trial
Official title:
Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center
| Verified date | September 2022 |
| Source | Roswell Park Cancer Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To identify the role of palliative medical management of inoperable malignant bowel obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple therapy.
| Status | Terminated |
| Enrollment | 15 |
| Est. completion date | September 3, 2021 |
| Est. primary completion date | September 3, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age = 18 years of age. - Diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy. - Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission. - Patient must have an inoperable MBO - Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related procedure. Exclusion Criteria: - Evidence of complete bowel obstruction by imaging. - Bacteremia/septicemia with a documented positive blood culture: If a blood culture comes back positive after study enrollment, patient will be excluded. - Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to study enrollment. - Patients undergoing bowel surgery or stent placement for bowel obstruction. - Those patients with MBO in setting of incarcerated hernia. - Known history of QT prolongation syndrome or if QTc is > 450 msec in males or > 470 msec in females on baseline EKG within 2 weeks of enrollment. - Lack of decision making capacity/delirium. - Pregnant or nursing female participants. - Actively suicidal patients. - Acute cholecystitis |
| Country | Name | City | State |
|---|---|---|---|
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Roswell Park Cancer Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Patients With Obstruction Clearance | The primary efficacy endpoint is the proportion of eligible patients whose malignant bowel obstruction clears (de-obstruction) within 7 days of starting the protocol therapy. Patients meeting de-obstruction criteria within 7 days will be deemed treatment successes.
De-obstruction is defined as: Effective introduction of oral intake (yes/no) Distinguished from small volumes of oral fluid that may be allowed with unresolved MBO Tolerating oral liquid diet (day 1 of de-obstruction) that is able to be progressively more solid (oral or enteral) Cessation of vomiting or ability for NGT or venting G tube to remain clamped without vomiting Rate of de-obstruction is defined as: - From the date of study enrollment to the first observation of de-obstruction. |
Within 7 days of starting protocol therapy |