Clinical Study on the Effect of Comprehensive Rehabilitation Program Plus Chemotherapy Versus Chemotherapy on Quality of Life in Postoperative Non Small Cell Lung Cancer Patients With Stage IB-IIIA
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Change from baseline in Quality of life (QOL)
研究概览
简要总结
The investigators performed a multi-centered, randomized, placebo-controlled, prospective clinical trial on the effect of comprehensive rehabilitation program plus chemotherapy to improve quality of life(QOL) and long-term survival of postoperative non small cell lung cancer（NSCLC）patients with high risk stages IB to IIIA. The investigators plan to enroll 354 cases in 3 years (118 cases for chemotherapy plus rehabilitation training and traditional Chinese medicine (TCM), 118 cases for chemotherapy plus rehabilitation education and TCM,118 cases for chemotherapy plus rehabilitation education and placebo), expecting that comprehensive rehabilitation program plus chemotherapy has a better efficacy on improving QOL and long-term survival.
详细描述
NSCLC is one of the malignancies with high incidence and mortality. In recent years, surgery become the preferred treatment for early stage of NSCLC. Patients with high risk stages IB to IIIA may undergo radical surgery and complete 4-6 cycles of adjuvant chemotherapy. 5 year survival rate increased from 43.5% to 48.8%, but some patients will end chemotherapy because of the side effects of chemotherapy. Comprehensive rehabilitation program may alleviate the side effects as an effective treatment which including rehabilitation training and TCM.
The investigators performed a multi-centered, randomized, placebo-controlled, prospective clinical trial on the effect of comprehensive rehabilitation program plus chemotherapy to improve quality of life(QOL) and long-term survival of postoperative patients who need complete postoperative chemotherapy with high risk stages IB to IIIA. Patients are randomized into A observational group (chemotherapy plus rehabilitation training and TCM), B observational group(chemotherapy plus rehabilitation education and TCM) and control group (chemotherapy plus rehabilitation education and placebo). The treatment should be last three months and the patients will be followed up regularly. The primary efficacy assessments are: (1) QOL (QLQ-LC43 scale); (2) Pulmonary function test(PFTs): 1) Forced vital capacity (FVC); 2) Forced expiratory volume in one second (FEV1); 3) Forced expiratory flow rate from 25% to 50% (FEF25-50); 4) Residual volume (RV); 5) Total lung capacity (TLC). Secondary efficacy assessments are: (1) 2 years disease-free survival; (2) TCM symptoms changes; (3) Tumer markers (CEA, CA-125 and CYFRA21-1); (4) Exercise tolerance; (5) Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators plan to enroll 354 cases in 3 years (118 cases for chemotherapy plus rehabilitation training and traditional Chinese medicine (TCM), 118 cases for chemotherapy plus rehabilitation education and TCM,118 cases for chemotherapy plus rehabilitation education and placebo), expecting that comprehensive rehabilitation program plus chemotherapy has a better efficacy on improving QOL and long-term survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with completely resected stage IB-IIIA non-small-cell lung cancer who will receive chemotherapy for the first time within 6 weeks after the operation.
- •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
排除标准
- •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;
研究组 & 干预措施
Chemotherapy+Training+TCM
Adjuvant Chemotherapy is performed within 6 weeks after operation. Rehabilitation training is mainly composed of gymnastic qigong, 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 four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.
干预措施: Rehabilitation Training (Behavioral)
Chemotherapy+Training+TCM
Adjuvant Chemotherapy is performed within 6 weeks after operation. Rehabilitation training is mainly composed of gymnastic qigong, 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 four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.
干预措施: TCM (Drug)
Chemotherapy+Education+TCM
Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training.
Prescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.
干预措施: TCM (Drug)
Chemotherapy+Education+TCM
Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training.
Prescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.
干预措施: Rehabilitation Education (Other)
Chemotherapy+Education+Placebo
Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training.
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.
干预措施: Rehabilitation Education (Other)
Chemotherapy+Education+Placebo
Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training.
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.
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in Quality of life (QOL)
时间窗: Time Frame: baseline, at 4 months
QOL is assessed using European Organization for Research and Treatment of Cancer Quality of Life QuestionnaireLung Cancer 43 (EORTC QLQ-LC43).
次要结局
- Residual capacity (RV)(after intervention at 2 weeks)
- Total lung capacity（TLC）(after intervention at 2 weeks)
- Maximum mid expiratory flow(MMEF)(after intervention at 2 weeks)
- Disease-free survival (DFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- TCM symptoms changes(after intervention at 4 months)
- Tumor markers(after intervention at 4 months)
- Safety assessment evaluated according to Common Toxicity Criteria(after intervention at 4 months)
- Forced vital capacity (FVC)(after intervention at 2 weeks)
- Forced expiratory volume in one second(FEV1)(after intervention at 2 weeks)