Clinical trial · Interventional
Efficacy Study of Comprehensive Rehabilitation Program in Postoperative NSCLC Patients
Clinical Study on the Effect of Comprehensive Rehabilitation Program on Quality of Life and Long-term Survival in Postoperative Non Small Cell Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators performed a multi-centered, randomized, placebo-controlled, prospective clinical trial on the effect of comprehensive rehabilitation program to improve quality of life(QOL) and long-term survival of postoperative patients with early lung cancer. The investigators plan to enroll 236 cases in 3 years (118 cases for rehabilitation training plus traditional Chinese medicine (TCM), 118 cases for rehabilitation education plus placebo), expecting that comprehensive rehabilitation program has a better efficacy on improving QOL and long-term survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| Rehabilitation Education | Other | — | UNRESOLVED |
| Rehabilitation Training | Other | — | UNRESOLVED |
| TCM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rehabilitation training plus TCM
- description
- Rehabilitation training include aerobic exercise training and Liu Zi Jue lung exercises, which will be started in one month after operation. Prescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe. Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.The patient will take TCM granules for 3 months.
- interventionNames
- Other: Rehabilitation Training
- Drug: TCM
- type
- PLACEBO_COMPARATOR
- label
- Rehabilitation education plus placebo
- description
- Patients who received rehabilitation education will not accept rehabilitation training. We compromise the raw materials for the placebo including food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages. The patient will take placebo granules for 3 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically or cytologically confirmed stage Ia-IIIa non small cell lung cancer; * Between the ages of 18 to 75 years old; * The score of ECOG ≥2 points * Without major organ dysfunction: hemoglobin ≥10 g/dL, absolute neutrophil count (ANC) ≥1.5\*10\^9/L, platelets ≥100 \*10\^9/L; normal hepatic and renal function Exclusion Criteria: * Indefinite pathological diagnosis; * Expected survival time \< 6 months * Combined with heart, liver, kidney and hematopoietic system and other serious diseases * The patient was treated with antibiotics or infected one week before the test; * Pregnant or child breast feeding women; * Mental or cognitive disorders;
References
Publications (1)
- DERIVEDQin X, Bi L, Yang W, He Y, Gu Y, Yang Y, Gong Y, Wang Y, Yan X, Xu L, Xiao H, Jiao L. Dysbiosis of the Gut Microbiome Is Associated With Histopathology of Lung Cancer. Front Microbiol. 2022 Jun 14;13:918823. doi: 10.3389/fmicb.2022.918823. eCollection 2022. PMID 35774470