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CTRI Number  CTRI/2025/05/086361 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On: 03/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Single Arm Study 
Public Title of Study   A study on using Polyethylene glycol and Bisacodyl to relieve constipation in people with advanced cancer receiving palliative care. 
Scientific Title of Study   Prospective observational single arm study evaluating Polyethylene glycol plus Bisacodyl for managing constipation in patients with advanced cancers under specialist palliative care 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayita Deodhar 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine, Tata Memorial Hospital, Dr Ernest Borges road, Parel, Mumbai – 400012 Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9892358023  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayita Deodhar 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine, Tata Memorial Hospital, Dr Ernest Borges road, Parel, Mumbai – 400012 Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9892358023  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Parth Sarthi Jha 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative Medicine, Tata Memorial Hospital, Dr Ernest Borges road, Parel, Mumbai – 400012 Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9538594038  
Fax    
Email  parthsjha@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital , Parel Mumbai 400012 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayita Deodhar  TATA MEMORIAL HOSPITAL  Palliative Medicine Department Main building Ground Floor Room number 75 Tata Memorial Hospital Parel,Mumbai, Maharashtra 400012 India Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9892358023

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Age 18 years or more and willing to participate
2.Referred to Department of Palliative Medicine with constipation more than or equal to 3 out of 10 in numerical rating score NOT on T Bisacodyl 5mg tablet + syrup PEG 20ml in 200ml water.
3.Able to communicate and understand English/Hindi/Marathi
4.Able to give written informed consent for questionnaire administration
5.Diagnosed case of advanced malignancy
 
 
ExclusionCriteria 
Details  1.Unstable medical condition requiring emergency treatment
2.Pre-existing Psychiatric disorder or cognitive impairment preventing patients from comprehending questionnaire
3.Known or suspected bowel obstruction or ileus
4.Presence of a colostomy or ileostomy
5.History of inflammatory bowel disease
6.Colorectal Primary Site of Cancer
7.Contraindication to any of the medication used Eg.Patients on Parenteral Hydration and nutrition only
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Frequency as percentage of responders
(Responders will be defined as having passed any bowel movement in 48 hours following initiation of laxative)
 
Baseline and 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1)To evaluate change in numerical rating score for constipation in Edmonton Symptom Assessment System- Revised –CS at 48 hours after initiation of laxative
2) To evaluate patient reported adverse effects at 48 hours
a) As reported by patients
b) In Edmonton Symptom Assessment System- Revised – CS: Other Problem row; with a numerical rating score 0 to 10
3) To understand the factors associated with effectiveness of laxative and contributing factors in non-responders
4) To understand the compliance to prescribed laxatives as per standard OPD practice
 
Baseline and 48 hours 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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   N/A 
Date of First Enrollment (India)   14/05/2025 
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="1"
Months="0"
Days="0" 
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  
Constipation is a common and distressing problem for patients with advanced cancer, often leading to discomfort and reduced quality of life. Many factors contribute to constipation in these patients, including reduced mobility, inadequate fluid intake, and the use of pain-relieving opioids. Despite various treatment options available, managing constipation effectively remains challenging.
This study aims to evaluate the effectiveness of a combination of two commonly used laxatives like Polyethylene Glycol ie PEG and Bisacodyl—in relieving constipation among patients receiving palliative care. PEG helps retain water in the intestines, softening stools, while Bisacodyl stimulates bowel movements.
The study will be conducted at the Tata Memorial Hospital’s Palliative Medicine Outpatient Department in Mumbai. It is a prospective observational study, meaning researchers will monitor and analyze patients’ responses to this treatment without altering standard medical care. Patients who meet the eligibility criteria and consent to participate will receive the PEG + Bisacodyl combination, and their bowel movements and symptom relief will be assessed  after 48 hours.
The primary goal is to determine the percentage of patients who have a bowel movement within 48 hours of starting the laxative.
Secondary objectives include assessing changes in constipation severity, patient-reported side effects, and adherence to the prescribed laxative regimen.
The findings from this study will help improve constipation management in palliative care settings, ensuring better comfort and quality of life for patients with advanced cancer.
 
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