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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
Intervention / Comparator Agent
|
|
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 |