A study conducted in multiple centers across India to assess breathlessness in advanced cancer patients

Completed

Conditions: Neoplasm of unspecified behavior of unspecified site,

Registration Number: CTRI/2021/10/037056

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Background and rationale: Dyspnea is defined as â€œan uncomfortable sensation of breathingâ€ (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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 288

Inclusion Criteria

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.

Exclusion Criteria

Patients with potential curable disease referred for early palliative care 2.
Patients for whom reliable contact number or method of communication is not available.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Screen for clinical dyspnea as shown on a 100-mm visual analog scale and identify the clinical prevalence of dyspnea	day 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6): Acharya Harihar Regional Cancer Centre
🇮🇳
Cuttack, ORISSA, India
All India Institute of Medical Sciences
🇮🇳
South, DELHI, India
Gujarat Cancer and Research Institute
🇮🇳
Ahmadabad, GUJARAT, India
Homi Bhabha Cancer Hospital and Research Centre
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Shri Siddhivinayak Ganpati Cancer Hospital
🇮🇳
Sangli, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Acharya Harihar Regional Cancer Centre
🇮🇳Cuttack, ORISSA, India
Sumita Mohanti
Principal investigator
9437022633
dr_sumita2007@yahoo.com