Health Condition 1: C786- Secondary malignant neoplasm of retroperitoneum and peritoneum
Conditions
Interventions
Intervention1: Dexamethasone, Metoclopramide,: The patients will receive IV dexamethasone 4 mg in the morning and 2 p.m. in the afternoon along with metoclopramide 10 mg IV q 8h. The prokinetic dose o
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 yrs and above Diagnosis of partial bowel obstruction related to malignancy with failure to respond, at 48 hours, to conservative measures such as bowel rest, implemented by nil per os, IV hydration, nasogastric tube NGT insertion based on patient preference and pantoprazole 40 mg IV OD. Radiological evidence of partial bowel obstruction with a CT abdomen and pelvis performed within 48-72 hours of the episode or if older imaging shows evidence of partial obstruction done less than a month ago. Partial versus complete bowel obstruction will be determined based on the definition that partial bowel obstruction indicates that some fluid or gas passes beyond the site of obstruction or transition point. Inoperable malignant bowel obstruction based on surgical consult and not amenable to stenting Not receiving active cancer directed therapy currently or patients who are on best supportive care.
Exclusion criteria
Exclusion criteria: Patients with evidence of complete bowel obstruction on radiological imaging Steroid equivalent of dexamethasone 8 mg per day in the 7d prior to enrollment History of QT prolongation of QTc more than 500 ms on screening ECG History of tardive dyskinesia or dystonia Actively taking antipsychotic medications History of seizures in 12 months prior to enrollment or taking maintenance anti-epileptic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the reduction in vomiting among patients with partial MBO who have received metoclopramide and dexamethasone.Timepoint: Baseline, 72 hours, 1 month, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain and nausea score at baseline and at the end of 72 hours using revised Edmonton symptom assessment scale (rESAS). 2. For the outcome of time to de-obstruction: Time since admission to first signal of resolution of bowel obstruction, where de-obstruction is defined as: Vomiting frequency 2 episodes or less per day Oral liquids of 500 ml per day NG tube drainage less than 200 ml per day and number of bowel movement (passage of flatus or faeces) at the end of 72 hours 3. To assess time since insertion of NGT to removal of NGT. 4. To assess time since Day 1 of intervention till the day that patient begins to tolerate 500 ml or more of oral liquids. 5. To assess the percentage of patients who needed octreotide. 6. Survival assessment at 1 month, 3 month and 6 months. Timepoint: 72 hours for symptoms of pain, nausea, vomiting Survival assessment at 1, 3,6 months | — |
Countries
India
Contacts
Public ContactMeenakshi V Venketeswaran
Cancer Institute (WIA) ,Adyar, Chennai
Outcome results
None listed