Effects of Jianpi Shengsui herbal formula cream on Chemotherapy-Related Fatigue for patients with lung cancer: a randomized double-blind controlled trial

The First Affiliated Hospital of Guangzhou University of Chinese Medcine0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

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•1 Patients who are diagnosed and confirmed as patients with non-small cell lung cancer (TNM stages IIIb to IV) based on pathology or cytology;
•2 Had fatigue after cancer diagnosis due to cancer therapy or the disease itself and RPFS score>=4.
•3 Drive gene is wild type or unknown.
•4 The Syndrome differentiation of traditional Chinese medicine accords with the diagnostic standard of qi and blood deficiency syndrome.
•5 Plan to undergo chemotherapy (TP/DP/AP scheme), at least two courses;
•6 Age range: 18 to 75;
•7 ECOG score 2 or below;
•8 Voluntarily joined this study with informed consents.
•9 Not using antidepressants and other psychotropic drugs for more than one-month.
•10 Patients who are willing to participate in surveys and the education background of who allows the independent completion of the questionnaires; Have clear consciousness, without suffering from a cognitive disorder or psychotic disorders.

•1 Treat with targeted medicine or PD1/PDL1 Immune checkpoint blockade therapy.
•2 Allergic to JPSS granules (including those who have allergies to any compositions of the prescription); Allergic to black beans or bean products.
•3 Infections which is uncontrollable;
•4 Had anemia, defined as hemoglobin lever< 9g/L or PLT< 50*10^9/L within two weeks of enrollment.
•5 Had thyroid disorder with abnormal thyroid stimulating hormone and free T4 level;
•6 Had any significant comorbidity, reduced oral intake with a serum protein level below the normal range or with severe insomnia or depression.
•7 Pregnant or lactating women.
•8 Suffering from the severe liver and kidney dysfunction (serum creatinine>=1.5 times ULN; ALT or AST>=1.5 times ULN; bilirubin>=1.5 times ULN), History of hepatitis A, B, or C;
•9 Current using of the following medications: ginseng, methylphenidate, modafinil, phenobarbital, diphenylhydantoin, primidone, phenylbutazone, monoamine oxidase inhibitors, clonidine, and tricyclic antidepressants.

发起方

The First Affiliated Hospital of Guangzhou University of Chinese Medcine