Palliative Management of Inoperable Malignant Bowel Obstruction

Roswell Park Comprehensive Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Malignant Bowel Obstruction

Treatments: Drug: Octreotide; Drug: Dexamethasone; Drug: Metoclopramide

Study type: Interventional

Funder types: Other

Identifiers

NCT04027348

I 74018

Details and patient eligibility

About

To identify the role of palliative medical management of inoperable malignant bowel obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple therapy.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Treatment (octreotide, dexamethasone, metoclopramide)

Experimental group

Description:

IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.

Treatment:

Drug: Octreotide

Drug: Dexamethasone

Drug: Metoclopramide