ABSTRACT
Background: Treatment for coronavirus disease 2019 (COVID-19) pneumonia remains largely supportive till date and multiple clinical trials took place within the short span of time to evaluate the role of investigational therapies. The anti-inflammatory effect of low dose whole lung radiation in treating pneumonia has been documented earlier. This clinical trial analyzed the effect of low dose radiation therapy (LDRT) in a moderately affected COVID-19 pneumonia patient cohort and has evaluated its effect in stopping the conversion of moderate disease into severe disease. Methods: Patients with moderate COVID-19 pneumonia as characterized by the Ministry of Health and Family Welfare (MOHFW), Government of India, were randomized (1:1) to low dose whole lung radiation versus no radiation. All treatment of patients was concurrently being given as per institutional protocol. Patients were followed up with clinical and laboratory parameters monitored on Days 1, 3, 7, and 14. Computed tomography scan (CT scan) of thorax was performed on Days 1 and 7. Patients were evaluated for conversion of moderate into severe disease as per National Early Warning Score-2 (NEWS-2 score) as the primary end point. The secondary endpoints included changes in ratio between peripheral capillary oxygen saturation and fraction of inspired oxygen (SpO2/FiO2), biochemical markers, 25-point CT severity score, and radiation induced acute pulmonary toxicities. Findings: At the interim analysis, there were seven patients in the radiation arm and six in the control. A whole lung LDRT improved the outcome of SpO2/FiO2 at Day 3; however it did not convert into a statistically significant improvement for the NEWS-2 score. The serum levels of LDH, CRP, Ferritin and D-dimer were significantly reduced on 14 days in the LDRT arm in comparison to the baseline value but were not significant between the two groups. Interpretation: LDRT seems to have the potential to prevent moderate COVID-19 pneumonia from a deteriorating to severe category. However, further randomized clinical trial with an adequate number of such patients is warranted to establish the definitive role of LDRT in the management of COVID-19 pneumonia. Funding: An intramural research project bearing code: I-27/621, was sanctioned from the All India Institute of Medical Sciences, Patna, India. Clinical Trial Registration: Clinical Trials Registry-India (CTRI/2021/06/033912, 25th May 2021) ctri.nic.in/Clinicaltrials/login.php.
ABSTRACT
BACKGROUND: With increasing incidence of cancer worldwide and increasing burden of treatment over the patients with cancer, the caregivers of those patients with cancer also suffer from psychological distress which ultimately affects their Quality of Life (QOL). This aspect is often overlooked which may ultimately lead to compromised patient care. PURPOSE: To translate the Caregiver Quality of Life Index-Cancer (CQOLC) Scale in Hindi and assess its association with Kesslers's psychological distress scale (K-10) for determining the quality of life (QoL) of caregivers of patients with cancer in India. METHODS: This is a single institute, hospital based cross sectional study performed from July 2020 to March 2021. Caregiver Quality of Life Index-Cancer (CQOLC) Scale, employing standard 'forward-backforward' translation procedure, the English-language version of the questionnaire was translated into Hindi-language by experts and administered to each caregiver. Cronbach's alpha was used for internal consistency. Kesslers's psychological distress scale (K-10) was analysed on interview basis. RESULTS: A total evaluated responders were 264. The hindi versions of the CQOLC was validated by cronbach's alpha method with internal consistency between 0.8 and 0.91. The majority of the caregivers were of the age group 31-40 yrs (42.05%). The male to female ratio was 6.54:1. CQOLC good score(0-45) was obtained in 27.27%, fair(46-90) in 55.30% and poor(91-140) in 17.42%. For K-10 distress scale very mild(10-19), mild(20-24), moderate(25-29) and severe(30-50) was observed in 47.73%, 11.74%, 11.74% and 28.79% respectively. A strong relation was found between the caregivers with poor CQOLC score and severe K-10 score(p<0.001). CONCLUSION: The Hindi version of CQOLC was accepted and its correlation with the point psychological distress predictor (K-10) scale was a valuable method to identify caregivers with poor QOL and severe distress levels.
Subject(s)
Neoplasms , Psychological Distress , Adult , Caregivers/psychology , Cross-Sectional Studies , Female , Humans , India , Language , Male , Neoplasms/therapy , Quality of Life/psychology , Reproducibility of ResultsABSTRACT
Background Treatment for coronavirus disease 2019 (COVID-19) pneumonia remains largely supportive till date and multiple clinical trials took place within the short span of time to evaluate the role of investigational therapies. The anti-inflammatory effect of low dose whole lung radiation in treating pneumonia has been documented earlier. This clinical trial analyzed the effect of low dose radiation therapy (LDRT) in a moderately affected COVID-19 pneumonia patient cohort and has evaluated its effect in stopping the conversion of moderate disease into severe disease. Methods Patients with moderate COVID-19 pneumonia as characterized by the Ministry of Health and Family Welfare (MOHFW), Government of India, were randomized (1:1) to low dose whole lung radiation versus no radiation. All treatment of patients was concurrently being given as per institutional protocol. Patients were followed up with clinical and laboratory parameters monitored on Days 1, 3, 7, and 14. Computed tomography scan (CT scan) of thorax was performed on Days 1 and 7. Patients were evaluated for conversion of moderate into severe disease as per National Early Warning Score-2 (NEWS-2 score) as the primary end point. The secondary endpoints included changes in ratio between peripheral capillary oxygen saturation and fraction of inspired oxygen (SpO2/FiO2), biochemical markers, 25-point CT severity score, and radiation induced acute pulmonary toxicities. Findings At the interim analysis, there were seven patients in the radiation arm and six in the control. A whole lung LDRT improved the outcome of SpO2/FiO2 at Day 3;however it did not convert into a statistically significant improvement for the NEWS-2 score. The serum levels of LDH, CRP, Ferritin and D-dimer were significantly reduced on 14 days in the LDRT arm in comparison to the baseline value but were not significant between the two groups. Interpretation LDRT seems to have the potential to prevent moderate COVID-19 pneumonia from a deteriorating to severe category. However, further randomized clinical trial with an adequate number of such patients is warranted to establish the definitive role of LDRT in the management of COVID-19 pneumonia. Funding An intramural research project bearing code: I-27/621, was sanctioned from the All India Institute of Medical Sciences, Patna, India. Clinical Trial Registration Clinical Trials Registry-India (CTRI/2021/06/033912, 25th May 2021) ctri.nic.in/Clinicaltrials/login.php
ABSTRACT
With the emergence of second wave of COVID-19 infection globally, particularly in India in March-April 2021, protection by massive vaccination drive has become the need of the hour. Vaccines have been proved to reduce the risk of developing severe illness and are emerging as vital tools in the battle against COVID-19. As per the GLOBOCAN database, nearly 19.3 million new cancer cases have been reported in 2020 globally, which posed a significant challenge to health care providers to protect such large number of 'vulnerable' patients from COVID-19. Nevertheless, a considerable degree of doubt, hesitancy and misconceptions are noted regarding the administration of vaccines particularly during active immuno-suppressant treatment. This review article highlights the added vulnerability of cancer patients to the COVID-19 infection and has explored the immunological challenges associated with malignancy, anticancer treatment and COVID-19 vaccination.