cancer related fatigue and radiation pneumonitis in patients with advanced NSCLC
Conditions
Interventions
Experimental group:Shenqi Fuzheng Injection (15 days). Subjects were administrated Shenqi Fuzheng Injection 250 mL intravenously for 3 weeks after enrollment, with dosing from 1-5 per week and discon
Control group:The treatment mode chosen by the physician (TCM injections and other TCM and health products that affect the evaluation of efficacy are prohibited).
Sponsors
HUAIHE HOSPITAL OF HENAN UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, method and possible adverse reactions of the test, volunteers as a subject, and signs an informed consent form before the start of the research procedure; 2. Male and female subjects aged 18 to 75 (including boundary values); 3. Meet one of the following conditions: (1) Patients with clear pathological diagnosis, ECOGPS = 3 months; 6. Moderate to severe fatigue with a score of 4 to 10 (including the cut-off value) on the Simple Fatigue Scale at the time of screening; 7. Good bone marrow reserve and liver and kidney function (whole blood neutrophil count >= 1.5*10^9/L, PLT >= 75*10^9/L, HB >= 90 g/L; liver and kidney function <= 1.5 times the normal range); 8. Fertile subjects (female or male) must agree to take effective contraceptive measures during the trial and at least 90 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Vital sign examination, physical examination, clinical laboratory examination, 12-lead electrocardiogram examination, imaging examination, any abnormality judged by the investigator to be clinically significant; 2. Those who have a history of allergies to Shenqi Fuzheng Injection and any drug components; those who have allergic constitution (such as two or more drugs, food allergies); those who have a history of allergies to similar traditional Chinese medicine injection preparations; 3.95% of the planned target volume (PTV) prescription dose < 60 Gy; 4. Patients with brain metastases; 5. Patients with severe chronic diseases or history of serious diseases and diseases that need to be excluded with abnormal clinical manifestations (including but not limited to): mental (especially anxiety, depression), nervous system, cardiovascular system, digestive system, respiratory system , blood and lymphatic system, rheumatic immune system, genitourinary system, endocrine and metabolic system and other system diseases; 6. Uncontrolled severe lung infection; 7. Patients after organ transplantation or taking immunosuppressive drugs for a long time; 8. Associated with malignant tumors or other malignant tumors diagnosed within 5 years before randomization (except for local cancers that have been cured obviously, such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell skin cancer, thyroid papillary cancer, etc.); 9. Those who have used other traditional Chinese medicines or health care products such as Fuzheng Yiqi in the past week, or long-term use of traditional Chinese medicines and health care products and cannot stop using them during the trial period (including but not limited to: decoctions, pills, powders, traditional Chinese medicine injections, etc.), Those who affect the judgment of curative effect; 10. Those who have received any major surgery within 6 months before the trial, or those who plan to undergo major surgery during the trial; 11. Subjects (including male subjects) have family planning or do not agree to take effective contraceptive measures in the next 6 months (including the trial period), or have plans for sperm donation and egg donation, and those who are pregnant or breastfeeding ; 12. Female subjects whose blood pregnancy test results were positive at the time of screening or who had unprotected sex within 14 days before screening; 13. Those who have participated in other drug clinical trials and taken experimental drugs 4 weeks before enrollment; 14. The investigator judges that it is not suitable to participate in this clinical research, or the subject voluntarily withdraws from this clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Revised Piper Fatigue Scale;Scale of symptoms of primary lung cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence (%) and severity of radiation pneumonitis;Cytokines (TGF-ß1, IL-1, IL-6, TNF-a);Incidence of Adverse Events; | — |
Countries
China
Contacts
Public ContactChen Na
HUAIHE HOSPITAL OF HENAN UNIVERSITY
Outcome results
None listed