Lung cancer
Conditions
Interventions
Experimental Group:Platinum-based chemotherapy + PD-1/PD-L1 inhibitors + Feifukang Granules (11g per dose, three times daily)
Control Group:Platinum-based chemotherapy + PD-1/PD-L1 inhibitors + Feifukang Granules placebo
Sponsors
Hunan Province Institute of Traditional Medicine Affiliated Hospital (Hunan Province Integrated Chinese and Western Medicine Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with Stage III-IV squamous cell carcinoma of the lung by pathology. 2.Planned to receive platinum-based doublet chemotherapy combined with PD-1/PD-L1 inhibitors for at least 2 cycles. 3.The clinical manifestations of the traditional Chinese medicine (TCM) syndrome of "Qi-Yin deficiency complicated by internal stagnation of blood stasis and toxin" are in accordance with the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Guidelines for Lung Cancer published by the Standardization Project Group for Integrated TCM and Western Medicine Diagnosis and Treatment of Lung Cancer in 2024. Diagnostic criteria are as follows: Major symptoms: 1) Fatigue and lack of energy; 2) Shortness of breath; 3) Cough with little phlegm, or 4) Blood streaks in sputum. Minor symptoms: 1) Dry mouth with little desire to drink; 2) Spontaneous sweating or night sweats; 3) Fear of wind; 4) Pale or lackluster complexion. Tongue and pulse: Red or pale red tongue, possibly with tooth marks, thin coating; fine and weak or deep and fine pulse. Syndrome determination: Patients meeting the criteria of >=2 major symptoms plus >=2 minor symptoms, along with consistent tongue and pulse manifestations, are eligible for enrollment. 4.A score of >=4 on the Piper Fatigue Scale-Revised (PFSR) at enrollment, indicating at least moderate fatigue. 5.Karnofsky Performance Status (KPS) score >=60, with an expected survival of >=3 months. 6.Aged 18–85 years, male or female. 7.Patients provide informed consent and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who do not meet the above diagnostic and inclusion criteria; 2. Patients with brain metastasis, bone metastasis with significant symptoms, and indications for palliative radiotherapy; 3. Patients with severe primary diseases of the heart, liver, kidneys, or hematopoietic system; 4. Patients with a history of mental illness or cognitive impairment who are unable to cooperate with the investigation; 5. Patients with known allergies to any components of the Lung Rehabilitation Granules; 6. Patients currently participating in other clinical studies that may affect fatigue assessment; 7. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer-related fatigue level; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM Syndrome Score;Physical performance;Quality of life;Inflammatory markers; | — |
Countries
China
Contacts
Public ContactOuyang Can
Hunan Provincial Institute of Integrated Traditional and Western Medicine Affiliated Hospital (Hunan Provincial Hospital of Integrated Traditional and Western Medicine)
Outcome results
None listed