CTRI

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CTRI Number

CTRI/2025/09/094485 [Registered on: 09/09/2025] Trial Registered Prospectively

Last Modified On:

09/09/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Single Arm Study

Public Title of Study

Managing Symptoms in Patients with Inoperable Malignant Bowel Obstruction using Dexamethasone and Metoclopramide: A multi-center study

Scientific Title of Study

Dexamethasone and metoclopramide in the management of patients with inoperable partial malignant bowel obstruction: A prospective, single-arm interventional multicentric trial.

Trial Acronym

DEXMET Trial

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Meenakshi V Venketeswaran
Designation	Associate Professor and In-charge Palliative Medicine
Affiliation	Cancer Institute (WIA) ,Adyar, Chennai
Address	Room No.206, Department of Pain and Palliative Care, IORT building, Second Floor, No. 38, Dr S. Krishnamurthy Campus, Sardar Patel Road, Adyar, Chennai-36 Chennai TAMIL NADU 600036 India
Phone	9940370735
Fax
Email	meenaram99@yahoo.com

Details of Contact Person
Scientific Query

Name	Meenakshi V Venketeswaran
Designation	Associate Professor and In-charge Palliative Medicine
Affiliation	Cancer Institute (WIA) ,Adyar, Chennai
Address	Room No.206, Department of Pain and Palliative Care, IORT building, Second Floor, No. 38, Dr S. Krishnamurthy Campus, Sardar Patel Road, Adyar, Chennai-36 Chennai TAMIL NADU 600036 India
Phone	9940370735
Fax
Email	meenaram99@yahoo.com

Details of Contact Person
Public Query

Name	Meenakshi V Venketeswaran
Designation	Associate Professor and In-charge Palliative Medicine
Affiliation	Cancer Institute (WIA) ,Adyar, Chennai
Address	Room No.206, Department of Pain and Palliative Care, IORT building, Second Floor, No. 38, Dr S. Krishnamurthy Campus, Sardar Patel Road, Adyar, Chennai-36 TAMIL NADU 600020 India
Phone	9940370735
Fax
Email	meenaram99@yahoo.com

Source of Monetary or Material Support

Cancer Institute (WIA), Adyar Chennai-36

Primary Sponsor

Name	Cancer Institute WIA
Address	No 38, Dr. S. Krishnamurthi Campus, Sardar Patel Road, Adyar, Chennai-600036
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 6
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Praneeth Suvvari	Basavatarakam Indo American Cancer Hospital & Research Institute	Road No. 10, IAS Officers Quarters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034 Hyderabad TELANGANA	9814686999 praneethsuv@gmail.com
Dr Meenakshi Vadakancheri Venketeswaran	Cancer Institute (WIA), Adyar, Chennai	No. 38, Dr S.Krishnamurthy Campus, Sardar Patel Road, Adyar, Chennai-36 Chennai TAMIL NADU	9940370735 meenaram99@yahoo.com
Dr Manu John	Caritas Hospital	Department of Palliative Medicine, Caritas Cancer Institute, Caritas Hospital, Thellakom, Kottayam, Kerala 686630 Kottayam KERALA	7558926577 dr.manujohn@caritashospital.org
Dr Vidya Viswanath	Homi Bhabha Cancer Hospital and Research Centre	Department of Palliative Medicine, Homi Bhabha Cancer Hospital and Research Centre, APIIC Industrial Park, Near Varun motors, Aganampudi Village, Gajuwaka Mandalam, Vishakhapatnam, Andhra Pradesh 530053 Visakhapatnam ANDHRA PRADESH	9848498412 drvidya21@gmail.com
Dr Somnath Dey	Mahamana Pandit Madanmohan Malaviya Cancer Centre	Department of Pain and Palliative Medicine, Mahamana Pandit Madanmohan Malaviya Cancer Centre, OPD Rom No-41, Sundar Bagiya, Nariya, Varanasi, Uttar Pradesh 221005 Varanasi UTTAR PRADESH	7595802711 somnath@mpmmcc.tmc.gov.in
Dr Pankaj Singhai	Sri Aurobindo Hospital	OPD 100, Cancer OPD, Sri Aurobindo Hospital, SAIMS Campus, Ujjain Road, Indore,453555 Indore MADHYA PRADESH	9920828452 doctorpsinghai@gmail.com

Details of Ethics Committee

No of Ethics Committees= 8
Name of Committee	Approval Status
Ethics Committee-Caritas hospital	Approved
HBCH RC Ethics Committeee	Submittted/Under Review
Institutional Ethics Committee	Approved
Institutional Ethics Committee	Approved
Institutional Ethics Committee	Approved
Institutional Ethics Committee	Submittted/Under Review
Institutional Ethics Committee	Approved
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C786\|\|Secondary malignant neoplasm of retroperitoneum and peritoneum,

Intervention / Comparator Agent

Type	Name	Details
Intervention	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 of metoclopramide is 10 mg three or four times a day, administered half an hour before meals and at bedtime. The central D2 antagonist effect of metoclopramide in the chemoreceptor trigger zone is only achieved with high doses 10 mg every 4–6 hours, orally or parenterally, maximum daily dose is 100 mg. Dose reductions are recommended in moderate to severe renal impairment, with a 50 percent decrease recommended if the creatinine clearance is 10–40 mL per min, and a 75 percent reduction if the creatinine clearance is less than 10 mL per min. In elderly patients, the initial dose should be at the lower end of the recommended adult range. In patients whose symptoms do not decrease within 24 hours the dose of metoclopramide will be increased to 20 mg IV TDS on the next day to a maximum of 30 mg TDS. The patients in whom there is resolution of symptoms will be allowed oral liquids gradually and if tolerated, changed to oral medications by day 5 and the patient will be discharged. Medications will be gradually weaned off at the physician’s discretion. Patients will be followed up at 1 month, 3 months and 6 months.
Comparator Agent	This a single arm trial with no comparator agent	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To assess the reduction in vomiting among patients with partial MBO who have received metoclopramide and dexamethasone.	Baseline, 72 hours, 1 month, 3 months and 6 months

Secondary Outcome

Outcome

TimePoints

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.

72 hours for symptoms of pain, nausea, vomiting
Survival assessment at 1, 3,6 months

Target Sample Size

Total Sample Size="67"
Sample Size from India="67"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

15/10/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="3"
Months="1"
Days="1"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Malignant bowel obstruction (MBO) is a serious complication in patients with ovarian and gastrointestinal malignancies with an incidence of 10-51percent. The patients suffer from a poor quality of life due to an increased symptoms such as pain, nausea and vomiting, and constipation. Further, the intolerance to orals adds to the necessity of hospitalization. In the setting of an inoperable bowel obstruction, not amenable to stenting, medical management remains the only option.

Octreotide is among the drugs frequently used in the medical management of MBO, by virtue of its ability to reduce gut wall edema and gastric and pancreatic secretions. However, a double-blind, placebo controlled, RCT involving 87 patients did not demonstrate a statistically significant reduction in the number of days free from vomiting despite addition of octreotide. Dexamethasone and metoclopramide are two other drugs which have been consistently used in partial bowel obstruction and found to relieve pain, nausea, vomiting, and improve motility. While dexamethasone has anti-inflammatory effects that reduce gut wall edema, it is also a centrally acting antiemetic. Metoclopramide is a prokinetic with antiemetic properties. NCCN recommends both drugs in the management of patients with partial IMBO. A recent study among patients with partial IMBO, supports the safety and efficacy of triple therapy with dexamethasone, metoclopramide and octreotide in reducing pain, nausea, constipation and resumption of oral intake. However, the sample size in this study was 15 patients and further studies are needed to confirm the findings. A retrospective cohort study examining the effect of the triple therapy on rate of de-obstruction was not significantly different from patients who did not receive all 3 drugs. While guidelines recommend the use of octreotide as an antiemetic, the evidence is not strong and its cost high in developing countries precluding its use in all settings. Further, our unpublished data shows that the majority of the patients achieve symptom control with metoclopramide and dexamethasone without the addition of octreotide. Hence, this study aims to explore the efficacy of the combination of dexamethasone with metoclopramide in reducing symptoms among patients with inoperable partial, bowel obstruction.