- 2024-01-01
- Integrative cancer therapies 23
- Yi Jiang
- Fang-Fang Liu
- Yu-Qing Cai
- Peng Zhang
- Xiao-Feng Yang
- Xiang-Yan Bi
- Ruo-Yan Qin
- Shi Zhang
- Ju-Hua Yin
- Li-Ping Shen
- Jia-Xiang Liu
- Ling-Shuang Liu
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 75
- Population
- 75 patients with completely resected stage IIIA non-small cell lung cancer (NSCLC) after adjuvant chemotherapy
- Methods
- Randomized 1:1 to receive oral decoctions based on Qi-Yin syndrome differentiation (TCM group) or observation (observation group) for 12 months
- Blinding
- Open-label
- Duration
- 12 months
- Funding
- Unclear
Objective
Powerful adjuvant strategies are required to improve the survival of patients with completely resected stage ΙΙΙA non-small cell lung cancer (NSCLC). We aimed to compare the efficacy of traditional Chinese medicine (TCM) treatment versus observation after adjuvant chemotherapy in these patients.Methods
Eligible patients were randomized 1:1 to receive either oral decoctions based on Qi-Yin syndrome differentiation (TCM group) or observation (observation group). The intervention lasted for 12 months. The primary endpoint was 1-year disease-free survival (DFS). Secondary endpoints were DFS, quality of life, regulatory T cells (Tregs), and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) on the surface of Tregs in peripheral blood. We used EORTC QLQ-LC43 to evaluate quality of life.Results
Between Apr 29, 2019, and Nov 11, 2021, 75 patients were randomly assigned to oral decoctions based on Qi-Yin syndrome differentiation (n = 38) or observation (n = 37). The full analysis set included 35 patients in the TCM group and 35 in the observation group. After a median follow-up of 24.2 months, oral decoctions based on Qi-Yin syndrome differentiation improved DFS compared with observation (HR 0.378, 95% CI: 0.157-0.912; P = .03). One-year DFS was 82.1% in the TCM group and 61.9% in the observation group (P = .06). Three months after randomization, scores of total health, role function, emotional function, and social function in the TCM group were higher than those in the observation group (P < .01 for all), scores of fatigue, pain, insomnia, appetite loss, constipation, cough, and chest pain were lower than those in the observation group (P < .05 for all); there was no significant difference in the proportion of Tregs between the TCM group and the observation group (P = .58); the proportion of CTLA-4+Tregs in the TCM group was lower than that in the observation group (P = .046). There were no adverse events that occurred in both groups.Conclusions
Oral decoctions based on Qi-Yin syndrome differentiation after adjuvant chemotherapy prolonged DFS, reduced the risk of disease recurrence and metastasis, improved quality of life, and down-regulated the proportion of CTLA-4+Tregs in completely resected stage ΙΙΙA NSCLC patients.Trial registration
Chinese Clinical Trial Register, No. ChiCTR1800019396. Date of registration: 9 November 2018.