Palliative Management of Inoperable Malignant Bowel Obstruction

NCT ID: NCT04027348

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2021-09-03

Brief Summary

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

Conditions

Malignant Bowel Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (octreotide, dexamethasone, metoclopramide)

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Given IV

Metoclopramide

Intervention Type: DRUG

Given IV

Octreotide

Intervention Type: DRUG

Given IV

Interventions

Dexamethasone

Given IV

Intervention Type: DRUG

Metoclopramide

Given IV

Intervention Type: DRUG

Octreotide

Given IV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Case, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

I 74018

Identifier Type: -

Identifier Source: org_study_id