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Efficacy and safety of Yifei Sanjie Recipe in the treatment of chemotherapy-related cancer-related fatigue in patients with non-small cell lung cancer: a N-of -1 multicenter randomized controlled trial

Efficacy and safety of Yifei Sanjie Recipe in the treatment of chemotherapy-related cancer-related fatigue in patients with non-small cell lung cancer: a N-of -1 multicenter randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047426
Enrollment
Unknown
Registered
2021-06-18
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

cancer-related fatigue

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with non-small cell lung cancer diagnosed by pathology or cytology; 2. Meet the diagnostic criteria for cancer-related fatigue; 3. The estimated survival time is more than 3 months, PS<=2, aged 18 to 80 years; 4. Patients who are not suitable for targeted drug therapy; 5. According to the guidelines, patients need to receive platinum-containing dual-drug-based chemotherapy, including AP (pemetrexed + cisplatin/carboplatin), TP (paclitaxel + cisplatin/carboplatin), DP (docetaxel) + Cisplatin/carboplatin), GP (gemcitabine + cisplatin/carboplatin); can be combined with anti-vascular drugs and immune checkpoint inhibitors; 6. Those who voluntarily accept the treatment of this program, can adhere to the follow-up visit as prescribed by the doctor and have good compliance.

Exclusion criteria

Exclusion criteria: 1. Any situation that may hinder the subject from completing the clinical trial process, including but not limited to serious, difficult to control organic disease or infection, unstable angina, congestive heart failure, etc.; hypothyroidism has not been controlled; 2. Severe liver and kidney dysfunction (serum creatinine >= 1.5 ULN; ALT or AST >= 5 ULN; bilirubin >= 1.5 ULN); 3. Patients with neurological or mental disorders who are symptomatic and difficult to control, and others who cannot complete the questionnaire independently or assist by others.

Design outcomes

Primary

MeasureTime frame
Brief fatigue inventory;Gut Microbiota;

Secondary

MeasureTime frame
Quality of life;Clinical symptom score;Immune Function;Neuroendocrine function;Mental Sleepy score and Mental Fatigue score;

Countries

China

Contacts

Public ContactCao Yang

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

393556828@qq.com+86 13802945884

Outcome results

None listed

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