Grade I and II neutropenia due to chemotherapy in primary non-small cell lung adenocarcinoma (Evidence of two deficiencies in essence and qi)
Conditions
Interventions
treatment group:Shuang Huang Shengbai Oral Liquid (specification: 20 ml/ bottle), 40 ml/ time, 2 times/day, oral
Take for 21 days
Control group:Shuang Huang Shengbai Oral Liquid simulator (specification: 20 ml/ bottle), 40 ml/ time, 2 times/day, oral.Take for 21 days
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: All of the following criteria must be met at screening to enter the trial: (1) Patients with a histologically or cytologically confirmed diagnosis of primary non-small cell lung adenocarcinoma; (2) Patients treated with chemotherapy who meet one of the following two criteria: ?Patients with primary treatment who meet the 8th edition AJCC lung cancer stage ?B-? without indications for surgery or radiotherapy (except local brain radiotherapy); ?Patients treated with post-operative chemotherapy for lung cancer; (3) Patients who have been diagnosed by a Chinese medicine practitioner specializing in oncology and meet the criteria for the identification of essence and qi deficiency; (4) Patients who are to be treated with a first-line chemotherapy regimen of pemetrexed in combination with cisplatin/carboplatin; and who occur grade ?~? neutropenia in the first chemotherapy cycle; (5) Those with an expected survival of = 6 months who can complete at least 2 cycles of chemotherapy; (6) ECOG score =1; (7) Age 18-75 years (including 18 and 75 years), regardless of gender; (8) Voluntary trial participants who have signed the informed consent form. Translated with www.DeepL.com/Translator (free version)
Exclusion criteria
Exclusion criteria: All of the following criteria must not be met at screening to enter the trial: (1) Patients who have received radiation therapy within 4 weeks prior to enrollment, or who are scheduled to receive radiation therapy concurrently during this trial; (2) History of previous bone marrow transplantation and/or stem cell transplantation; (3) Have a primary haematological disorder such as myelodysplastic syndrome, aplastic anaemia, sickle cell anaemia, etc; (4) Those with uncontrollable infections (ANC = 12.0 x 10^9/L and/or axillary temperature > 38.2°C); (5) Those with septic and/or chronic infections with prolonged wounds (6) Those with a combination of serious primary diseases of the heart, liver, kidney and haematopoietic system; laboratory tests will not be included if any of the following are met: ? ? ALT = 2.5 ULN (no liver metastases) ? ? AST = 2.5 ULN (no liver metastases) ? ? TBIL = 1.5 ULN (no liver metastases) ? ?ALT=5ULN (with liver metastases) ? ? AST = 5ULN (with liver metastases) ? ?TBIL=3ULN (with liver metastases) ? ?Scr=1.25ULN (7) Patients with poorly controlled diabetes mellitus (those with HbA1c = 7%); (8) A diagnosis of another primary malignancy in addition to non-small cell lung cancer within the last 3 years, with the exception of completely resected basal cell carcinoma and squamous cell skin carcinoma, and completely resected carcinoma in situ of any type; (9) Hypersensitivity to the chemotherapeutic drug or test drug (known component) of this regimen and its excipients (10) Persons with a history of drug or alcohol abuse; (11) Women who are pregnant or breastfeeding; (12) Persons who have participated in a clinical trial within 4 weeks prior to participation in this clinical trial or are participating in any clinical trial (13) Persons with serious psychiatric or neurological disorders that interfere with informed consent and/or the presentation or observation of adverse reactions; (14) Other conditions deemed unsuitable for participation in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutrophils; | — |
Secondary
| Measure | Time frame |
|---|---|
| leukocyte;Curative effect of TCM syndrome;The Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale; | — |
Countries
CHINA
Contacts
Public ContactTian Shaodan
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed