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CTRI Number  CTRI/2021/10/037056 [Registered on: 04/10/2021] Trial Registered Prospectively
Last Modified On: 06/07/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A study conducted in multiple centers across India to assess breathlessness in advanced cancer patients 
Scientific Title of Study   Point prevalence of dyspnea, quality, and effect of Dyspnea management in ambulatory patients with advanced cancer: A Multi-center Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuja Damani 
Designation  Associate Professor, Palliative Medicine 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, Main Building, G-75, Dr. Ernest Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  anuja.damani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anuja Damani 
Designation  Associate Professor Palliative Medicine 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, Main Building, G-75, Dr. Ernest Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  anuja.damani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anuja Damani 
Designation  Associate Professor Palliative Medicine 
Affiliation  Tata Memorial Centre 
Address  Tata Memorial Hospital, Main Building, G-75, Dr. Ernest Borges road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  anuja.damani@gmail.com  
 
Source of Monetary or Material Support  
Non funded trail. Patients will be recruited in hospital/ institutional facilities. 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, G-75, Main Building, Dr Ernest Borges Rd, Parel, Mumbai-12 
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 
Sumita Mohanti  Acharya Harihar Regional Cancer Centre  Dept of Anaesthesiology,pain&palliative care Acharya Harihar Regional Cancer centre, Cuttack - 753007
Cuttack
ORISSA 
9437022633

dr_sumita2007@yahoo.com 
Sushma Bhatnagar  All India Institute of Medical Sciences  Department of Onco-anaesthesia, Pain and Palliative Medicine, AIIMS- IRCH, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI 
9811326453

sushmabhatnagar1@gmail.com 
Priti Sanghavi  Gujarat Cancer and Research Institute  Department of Palliative Medicine at The Gujarat Cancer & Research Institute- Ahmedabad-380016
Ahmadabad
GUJARAT 
9825420656

drpritisanghavi@gmail.com 
Vidya Vishwanath  Homi Bhabha Cancer Hospital and Research Centre  Dept of Palliative Medicine Homi Bhabha Cancer Hospital and Research Centre, Aganampudi , Visakhapatnam - 530053
Visakhapatnam
ANDHRA PRADESH 
9848498412

drvidya21@gmail.com 
Amit Grover  Shri Siddhivinayak Ganpati Cancer Hospital  Shri Siddhivinayak Ganpati Cancer Hospital, Sangli Road, Miraj - 416410
Sangli
MAHARASHTRA 
9860482449

amgroovy2000@yahoo.com 
Anuja Damani  Tata Memorial Hospital  Department of Palliative Medicine Main Building, G 75, Dr. Ernest Borges Road Parel, Mumbai - 400012
Mumbai
MAHARASHTRA 
9158437827

anuja.damani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Acharya Harihar Regional Cancer Center  Approved 
All India Institute of Medical Sciences  Approved 
GCRI/GCS Ethics Committee  Approved 
Homi Bhabha Cancer Hospital and Research Centre  Approved 
Institutional Ethics Committee, Sanjeevan Medical Foundation  Approved 
Tata Memorial Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. to have pathologically diagnosed cancer, and have been informed of their diagnosis
2. to have an advanced clinical stage or recurrence
3. to be 18 years or older
4. to be well enough to complete the questionnaire
5. to not to be suffering from severe mental or cognitive disorder 
 
ExclusionCriteria 
Details  1. Patients with potential curable disease referred for early palliative care
2. Patients for whom reliable contact number or method of communication is not available 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Screen for clinical dyspnea as shown on a 100-mm visual analog scale and identify the clinical prevalence of dyspnea  day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Identify the quality of dyspnea by Cancer Dyspnea Scale (CDS)  day 1, 3 and 7 
To identify the effect of dyspnea management on daily life activities and quality of life of patients using EORTC QLQ-C15 pal.   day 1, 3 and 7 
To record the dosage of opioids/ 24 hours used to manage dyspnea in Oral Morphine Equivalents (OME) and changes in VAS -D   day 1, 3 and 7 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
Final Enrollment numbers achieved (Total)= "288"
Final Enrollment numbers achieved (India)="288" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2021 
Date of Study Completion (India) 30/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Background and rationale: Dyspnea is defined as “an uncomfortable sensation of breathing” (1). It is one of the most common symptoms in advanced cancer patients, regardless of cancer site. In a previous study in
our center, we found that prevalence of dyspnea in advanced cancers is 44.37% (2). It is very distressing for
the patient as well as the caregivers and is difficult to manage. These patients with advanced cancers may suffer from refractory dyspnea, which is associated with other symptoms and psycho-social concerns (3). Hence it is important to use a multi-dimensional tool for assessment of dyspnea in such patients. Management of dyspnea involves multimodal nonpharmacological and pharmacological treatments. One of 
the commonly used drugs to manage refractory dyspnea is Morphine sulfate (4). It modulates the perception of dyspnea by binding to opioid receptors. Proposed mechanisms whereby opioids relieve refractory dyspnea include: decreasing respiratory drive with an associated decrease in corollary discharge; altering central perception; altering activity of peripheral opioid receptors located in the lung and decreasing anxiety (5). The clinical prevalence, quality and management of dyspnea varies in the country, and there is little literature on this aspect (6). It is thus worthwhile to investigate this in a multicentric trial.

Aims: The aim of this study is to know the clinical prevalence, quality of dyspnea, use of opioids in the management of dyspnea in advanced cancer patients in multiple centers in India and to look at the effect of dyspnea management on the Quality of Life of these patients. Objectives Primary objective Screen for clinical dyspnea as shown on a 10-cm visual analog scale and identify the clinical prevalence of dyspnea Secondary objectives 1. Identify the quality of dyspnea by Cancer Dyspnea Scale (CDS) 2. To identify the effect o dyspnea management on daily life activities and Quality of Life of patients. 3. To record the dosage* of opioids/ 24 hours used to manage refractory dyspnea$ in Oral Morphine Equivalents (OME) and changes in VAS-D at 1, 3, and 7 days. *if opioids are used for pain, then the additional amount of opioid required to manage dyspnea is to be noted. $ refractory dyspnea is breathing difficulty that persists at rest or with minimal activity despite optimal therapy of the underlying condition (5) 

Longitudinal study

Prospective observational multi centric study. Tata Memorial Hospital, Mumbai will be the coordinating center. The other participating sites invited for this study are Palliative Medicine Departments of: 1. Acharya Harihar Regional Cancer Centre, Cuttack 2. Homi Bhabha Cancer Hospital and Research Centre, Visakhapatnam 3. Shri Siddhivinayak Ganapati Cancer Hospital, Miraj 4. All India Institute of Medical Sciences, Delhi 5. The Gujarat Cancer & Research Institute, Ahmedabad 

 

 
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