| CTRI Number |
CTRI/2025/07/091818 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Can timely pain relief medicines improve quality of life in cancer patients? |
|
Scientific Title of Study
|
Effect of multimodal pain management on the quality of life of adult cancer
patients |
| 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 Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH, Sector-32B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaahujameetings2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH, Sector-32B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaahujameetings2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anushka Garai |
| Designation |
Postgraduate Student |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, GMCH, Sector-32B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9007907692 |
| Fax |
|
| Email |
anushkagarai99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32B, Chandigarh, India. Pin Code-160030 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Department of Anaesthesia and Intensive Care, GMCH, Sector-32B, Chandigarh, India
Pin Code-160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Vanita Ahuja |
Government Medical College and Hospital, Chandigarh |
Department of Anaesthesia and Intensive Care, Level-5, Room N0-521, GMCH, Sector-32B, Chandigarh
Chandigarh
CHANDIGARH |
9646121649
vanitaahujameetings2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College and Hospital, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G893||Neoplasm related pain (acute) (chronic), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of cancer with NRS more than or equal to 3
Able to read and write English or Hindi |
|
| ExclusionCriteria |
| Details |
Cancer disease that was too severe for them to complete the questionnaire.
Patients with severe infection, respiratory failure, severe hepatic or renal failure.
Women who were pregnant or lactating.
Those with a history of opioid dependence and on Naltreoxone.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the quality of life of adult cancer
patients using EORTCQLQ-C30. |
1 month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure NRS scores of cancer patients |
Baseline, 1 week follow-up, 1 month follow-up |
| To measure quality of life using EORTCQLQ-C30 |
Baseline, 1 week follow-up |
| To measure quality of life using WHOQOL-BREF, ESAS-r |
Baseline, 1 week follow-up, 1 month follow-up |
| To find any adverse events during pain management using multimodal analgesia |
Baseline, 1 week follow-up, 1 month follow-up |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
20/08/2025 |
| 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
|
This is a prospective observational interventional study designed to evaluate the effect of multimodal pain management on the quality of life of adult cancer patients. The study will be conducted at the Pain Clinic, Department of Anaesthesia and Intensive Care, in collaboration with the Department of Radiotherapy at Government Medical College and Hospital, Chandigarh. |