Effects of Jianpi Shengsui herbal formula cream on Chemotherapy-Related Fatigue for patients with lung cancer: a randomized double-blind controlled trial
- Conditions
- one small cell lung caner
- Registration Number
- ITMCTR1900002369
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou University of Chinese Medcine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The revised Piper fatigue scale score(RPFS);
- Secondary Outcome Measures
Name Time Method Tumor evaluation;EORTC QTQ-LC43;