Non-small Cell Lung Cancer Clinical Trial
Official title:
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
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.
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.
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