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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023451
Enrollment
Unknown
Registered
2019-05-28
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None small cell lung caner

Interventions

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medcine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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=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.

Design outcomes

Primary

MeasureTime frame
The revised Piper fatigue scale score(RPFS);

Secondary

MeasureTime frame
EORTC QTQ-LC43;Tumor evaluation;

Countries

China

Contacts

Public ContactXiao Zhiwei

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medcine

topcoolwei@163.com+86 13929538627

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026