An interventional study of Chai-Gui Jieyu Qufa Placebo Granules and Chai-Gui Jieyu Qufa Granules in Lung Adenocarcinoma, Cancer-related Fatigue and Liver Depression and Spleen Deficiency Syndrome (Traditional Chinese Medicine), sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Not applicable, Interventional, and Supportive care
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.
315 studies on the registry are indexed under Adenocarcinoma of Lung; 83 are open to participants now.
This study's enrollment of 120 is above the median of 62 across 220 interventional studies indexed under Adenocarcinoma of Lung.
Browse Adenocarcinoma of Lung studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 387 studies on the registry; 275 are open to participants now.
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Traditional Chinese herbal granules. Participants take the granules orally for the treatment of cancer-related fatigue.
Drug: Chai-Gui Jieyu Qufa Granules
Placebo granules, identical in appearance, smell and taste to the active herbal granules. Oral administration.
Other: Chai-Gui Jieyu Qufa Placebo Granules
In the control group, on the basis of platinum plus pemetrexed plus PD-1/PD-L1 inhibitor therapy, participants receive Chai-Gui Jieyu Qufa placebo (1/10 strength of Chai-Gui Jieyu Qufa formula). The route of administration and treatment duration are identical to those in the experimental group.
Chai-Gui Jieyu Qufa Granules, a compound traditional Chinese herbal granule preparation. Oral administration, twice daily for 21days, combined with first-line platinum + pemetrexed + PD-1/PD-L1 inhibitor therapy for cancer-related fatigue.
BFI scale will be used to evaluate the severity of cancer-related fatigue in patients of the two groups.
Time frame: 21days
Change in Traditional Chinese Medicine (TCM) syndrome score
The TCM syndrome score is used to assess the improvement of traditional Chinese medicine symptoms. The change from baseline in total TCM syndrome score will be compared between groups.
Time frame: 21days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Dec 2025, 23 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences →