| 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
|
|
|
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
|
|
|
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. |