Status and phase
Conditions
Treatments
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
236 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal