NCT07890051Completed
Chaigui Jieyu Qufa Decoction for CRF in Driver Gene-negative Lung Adenocarcinoma Trial
A Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Trial of Chaigui Jieyu Qufa Decoction Versus Placebo in Cancer-related Fatigue of Driver Gene-negative Lung Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
The goal of this \[clinical trial\] is to \[evaluate whether Chaiyu Jieyu Qufa Decoction can improve cancer-related fatigue and assess its safety\] in \[patients aged 18-80 years with untreated lung adenocarcinoma complicated with cancer-related fatigue of liver depression and spleen deficiency syndrome, who are scheduled to receive first-line platinum plus pemetrexed combined with PD-1/PD-L1 therapy\]. The main question\[s\] it aims to answer \[is/are\]: \[Does Chaiyu Jieyu Qufa Decoction reduce the severity of cancer-related fatigue measured by the Brief Fatigue Inventory (BFI) in patients with lung adenocarcinoma receiving platinum+pemetrexed+PD-1/PD-L1 treatment\]? \[Does Chaiyu Jieyu Qufa Decoction improve traditional Chinese medicine syndrome scores, fatigue-related quality of life, general quality of life, anxiety and depression status, tumour objective response rate and progression-free survival, without increasing safety risks\]? If there is a comparison group: Researchers will compare \[patients receiving Chaiyu Jieyu Qufa Decoction plus standard anti-tumour therapy\] to \[patients receiving placebo simulation agent plus the same standard anti-tumour therapy\] to see if \[the active herbal intervention achieves better relief of cancer-related fatigue and related secondary endpoints with acceptable safety\]. Participants will Receive platinum plus pemetrexed combined with PD-1/PD-L1 immunotherapy as standard first-line anti-tumour treatment; Take either Chaiyu Jieyu Qufa Decoction or matching simulation agent orally, 200 mL twice daily for 21 days; Complete questionnaire assessments including BFI, FACIT-F, EORTC QLQ-C30 and HADS at scheduled time points; Undergo blood, urine and stool tests plus liver and kidney function tests for safety evaluation; Receive contrast-enhanced imaging examinations to evaluate tumour response at specified follow-up time points; Attend follow-up visits up to 333 days after study enrolment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 16 Oct 2026
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Lung cancer
- NCT number
- NCT07890051
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 1 Jan 2024 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving other treatments or medications that may affect cancer-related fatigue (CRF), such as acupuncture, ginseng, methylphenidate, modafinil, phenobarbital, phenytoin, primidone, phenylbutazone, monoamine oxidase inhibitors, benzodiazepines, clonidine and tricyclic antidepressants.
- Systemic steroid therapy within the past 6 months.
Other illness
- Patients with severe cardiovascular and cerebrovascular diseases or severe hepatic and renal impairment.
- History of psychiatric disorders including depression, obsessive-compulsive disorder or schizophrenia.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- Meet the western medicine diagnostic criteria for lung adenocarcinoma and cancer-related fatigue.
- Meet the traditional Chinese medicine diagnostic criteria for the syndrome of liver depression and spleen deficiency.
- Treatment-naive patients without prior anti-tumor therapy who are admitted to hospital for first-line treatment.
- Patients with lung adenocarcinoma planned to receive at least 2 cycles of platinum plus pemetrexed plus PD-1/PD-L1 inhibitor therapy.
- Hemoglobin concentration ≥90 g/L at enrollment.
- No concomitant or previous history of other primary malignant tumors.
- Aged 18-80 years old, with expected survival \> 3 months.
- Karnofsky Performance Status (KPS) score ≥60.
- Normal cognitive ability and capable of completing questionnaires.
- Voluntarily accept the study treatment regimen and sign the informed consent form.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.