Non-small Cell Lung Cancer Clinical Trial
Official title:
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
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.
Non-Small-Cell Lung Cancer（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 stage IA-IIIA lung cancer can undergo radical surgery, but postoperative lung
cancer patients also have shortness of breath, chest pain, cough, expectoration, upper limb
dysfunction and other symptoms. The symptoms seriously affect the quality of life and
follow-up treatment. Comprehensive rehabilitation program may alleviate the symptoms 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 to improve quality of
life(QOL) and long-term survival of postoperative patients who are not recommended for
postoperative chemotherapy at stage IA and IB. Patients are randomized into observational
group (rehabilitation training plus TCM), and control group (rehabilitation education plus
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 236 cases in 3 years (118
cases for rehabilitation training plus TCM, 118 cases for rehabilitation education plus
placebo), expecting that comprehensive rehabilitation program has a better efficacy on
improving QOL and long-term survival.
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