Clinical trial NCT03244605: Efficacy Study of Comprehensive Rehabilitation Program in Postoperative NSCLC Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
name: Shanghai Cancer Hospital, China
name: Huadong Hospital
First posted: 2017-08-09
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Change from baseline in Quality of life (QOL)
timeFrame: baseline, at 3 months
Secondary outcomes:
measure: Residual capacity (RV)
timeFrame: after intervention at 2 weeks
measure: Total lung capacity（TLC）
timeFrame: after intervention at 2 weeks
measure: Forced vital capacity (FVC)
timeFrame: after intervention at 2 weeks
measure: Forced expiratory volume in one second(FEV1)
timeFrame: after intervention at 2 weeks
measure: Maximum mid expiratory flow(MMEF)
timeFrame: after intervention at 2 weeks
measure: Disease-free survival (DFS)
timeFrame: 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
measure: TCM symptoms changes
timeFrame: after intervention at 3 months
measure: Tumor markers
timeFrame: after intervention at 3 months
measure: Safety assessment evaluated according to Common Toxicity Criteria
timeFrame: after intervention at 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Ling Xu, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qin 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.