Comparative study of the effectiveness of low-dose lung radiation in comparison with placebo in the treatment of cancer patients with severe inflammatory phase of covid19 pneumonia

Comparison of the effectiveness of low-dose lung radiotherapy compared with placebo in the treatment of the sever phase of the inflammatory phase of Covid-19 pneumonia

Clinical trial with control group, double-blind, randomized, on 36 patients. Spss20 software was used for randomization.

This double-blind study is performed on cancer patients who are currently in the severe inflammatory phase of Covid-19 pneumonia and are hospitalized in Omid Hospital in Isfahan. Patients in both groups will receive treatments based on the Covid-19 treatment protocol. Patients in the intervention group will receive pulmonary radiotherapy at a dose of 5 Gy in one fraction. Then the extent of lung involvement and the level of inflammatory factors and the hospitalization duration in both groups will be compared. In this study, patients, researchers and statistical analysts will be blinded and unaware of the placement of individuals in intervention or control groups.

Inclusion: Adult patients with underlying cancer who are currently in the severe inflammatory phase of Covid-19 pneumonia. exclusion: Patients who for any reason have contraindications to chest radiotherapy or are receiving radiotherapy treatment in this area.

intervention group will undergo contouring of lungs and vital organs after performing CT simulation. They will undergo a single radiation fraction to both lungs at a dose of 5 Gy. positioning and adjusting the device for Patients in the control group will be similar to the intervention group, and instead of receiving radiation, laser light will be used for them. The duration of receiving radiation, as well as all measures related to setting the device will be the same in both groups.

Duration of hospitalization ; Lung involvement; reduction of inflammatory factors

All patients wishing to participate in the study will be randomly divided into two groups A and B using SPSS20 software.To perform randomization by SPSS software, the "Data" option is selected from the SPSS software toolbar, then in the new window, the "Select cases" option is selected, then in the "Select" box, the "Random sample of cases" option is selected, and then the "Sample" option is selected. Then, in the new window, the "Exactly" option is selected and the number of patients in each group and the total number of samples are entered in the empty boxes, respectively (in this study, 18 and 36, respectively). Then the" Continue" and "Ok" options are selected and finally the randomly generated variables are randomly divided into two equal groups with codes 0 and 1 in the Data View page, which is conventionally assigned code 1 to the intervention group and code 0 to the control group. Patients will be randomly assigned to intervention or control groups by someone other than the lead researcher and statistical analyst.

This study is performed by double-blind method. Patients participating in the study will be explained that they may be in one of two groups of doing radiotherapy or not doing radiotherapy. The process of radiotherapy, including patient and device setup, will be performed similarly for both groups, and whether or not radiation is received will be based on the patients' position in the intervention or control group. During the study process, participants, researchers, evaluators and Analyst will not know how people are positioned in the groups, and this information will be kept during the study and until the end of study, by coordinator of the intervention (radiotherapy technician).