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Clinical study of injectable astragalus polysaccharide for the prevention of cancer-induced fatigue caused by chemotherapy in lung cancer

Clinical study of injectable astragalus polysaccharide for the prevention of cancer-induced fatigue caused by chemotherapy in lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068199
Enrollment
Unknown
Registered
2023-02-09
Start date
2023-02-15
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

cancer related fatigue

Interventions

Intervention group:Astragalus polysaccharides for injection+Paclitaxel for injection (albumin bound type) + carboplatin for injection
control group:placebo+Paclitaxel for injection (albumin bound type) + carboplatin for injection

Sponsors

Guanganmen Hospital, Chinese Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (1) NSCLC patients with stage III-IV confirmed by pathology or cytology and unable to undergo surgical treatment; (2) Patients who plan to undergo initial chemotherapy; (3) Physical condition score ECOG 0-1; (4) There was no CRF in BFI evaluation; (5) The skin test of astragalus polysaccharide for injection was negative; (6) Age 18-75; (7) Estimated survival time = 3 months (8) Subjects have no major organ dysfunction.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Patients with previous chemotherapy (2) Chemotherapy concurrent with radiotherapy, targeted therapy and immunotherapy (3) Evaluation of people with fatigue symptoms by BFI (4) People with a history of uncontrollable mental illness (5) People who are allergic to the study drug (6) Those who cannot understand and refuse to sign the informed consent form (7) Unable to cooperate with the meter data collector (8) Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Incidence of CRF;CRF degree;

Secondary

MeasureTime frame
Clinical symptoms (MDASI-LC);quality of life (EORTCQLQ-C30);kps score?ECOG score;immune markers (CD4, CD8, NK, etc.);hemoglobin;Neutrophils;PLT;ORR;DCR;

Countries

China

Contacts

Public Contacthouwei

Guanganmen Hospital, Chinese Academy of Chinese Medical Sciences

wangxy6636@163.com+86 13701361625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026