Chaigui Jieyu Qufa Decoction for CRF in Driver Gene-negative Lung Adenocarcinoma Trial

NCT07890051 — Not applicable, Completed, 120 participants, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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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

Registry	NCT07890051, acronym CJQD-CRF
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, supportive care
Enrollment	120 (Actual)
Sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Conditions	Lung Adenocarcinoma, Cancer-related Fatigue, Liver Depression and Spleen Deficiency Syndrome (Traditional Chinese Medicine)
Interventions	Chai-Gui Jieyu Qufa Placebo Granules, Chai-Gui Jieyu Qufa Granules (Other, drug)
Dates	start 2024-01-01, primary completion 2025-12-01, completion 2025-12-31, first posted 2026-10-22, last updated 2026-10-22
Locations	1 site in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Chai-Gui Jieyu Qufa Granules	Experimental	Drug: Chai-Gui Jieyu Qufa Granules	Traditional Chinese herbal granules. Participants take the granules orally for the treatment of cancer-related fatigue.
Chai-Gui Jieyu Qufa Placebo Granules	Placebo comparator	Other: Chai-Gui Jieyu Qufa Placebo Granules	Placebo granules, identical in appearance, smell and taste to the active herbal granules. Oral administration.

Chai-Gui Jieyu Qufa Placebo Granules (Other): 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 (Drug): 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.

+Outcome measures

Primary outcomes

BFI scale will be used to evaluate the severity of cancer-related fatigue in patients of the two groups. [21days]

Secondary outcomes

Change in Traditional Chinese Medicine (TCM) syndrome score [21days]: 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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

1. Meet the western medicine diagnostic criteria for lung adenocarcinoma and cancer-related fatigue.
2. Meet the traditional Chinese medicine diagnostic criteria for the syndrome of liver depression and spleen deficiency.
3. Treatment-naive patients without prior anti-tumor therapy who are admitted to hospital for first-line treatment.
4. Patients with lung adenocarcinoma planned to receive at least 2 cycles of platinum plus pemetrexed plus PD-1/PD-L1 inhibitor therapy.
5. Hemoglobin concentration ≥90 g/L at enrollment.
6. No concomitant or previous history of other primary malignant tumors.
7. Aged 18-80 years old, with expected survival > 3 months.
8. Karnofsky Performance Status (KPS) score ≥60.
9. Normal cognitive ability and capable of completing questionnaires.
10. Voluntarily accept the study treatment regimen and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe cardiovascular and cerebrovascular diseases or severe hepatic and renal impairment.
2. 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.
3. History of psychiatric disorders including depression, obsessive-compulsive disorder or schizophrenia.
4. Systemic steroid therapy within the past 6 months.
5. Pregnant or breastfeeding women.

+Locations (1)

Facility	City	Country	Status
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	China