Efficacy Study of Comprehensive Rehabilitation Program in Postoperative NSCLC Patients

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03244605
• Other study ID #: SHUTCM001
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: October 1, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2019
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 236
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• Rehabilitation Training
Patients will be trained in one month after operation. Rehabilitation training include aerobic exercise training (using cycle ergometer for 7-14 times at all, once a day, 15-20 min/time and using treadmill for 7-14 times at all, once a day, 15-20 min/time according to the patient's endurance) and Liu Zi Jue lung exercises, which strengthen the lung function of the human body in Chinese traditional health culture, five times a week, 15 min/time.
• Rehabilitation Education
General health education

Drug:
• TCM
three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.
• placebo
three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe,with the same color, smell,taste weight and package

Locations

Country	Name	City	State
China	YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Huadong Hospital, Shanghai Cancer Hospital, China, Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Quality of life (QOL)	QOL is assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 43 (EORTC QLQ-LC43).	baseline, at 3 months
Secondary	Residual capacity (RV)	RV is measured in a test known as Lung valume(LV)spirometry,a type of pulmonary function test.RV is the volume of air remaining in the lungs after a maximal expiratory effort.	after intervention at 2 weeks
Secondary	Total lung capacity(TLC)	TLC is measured in a test known as Lung valume(LV)spirometry,a type of pulmonary function test.TLC equals the vital capacity plus the residual capacity.	after intervention at 2 weeks
Secondary	Forced vital capacity (FVC)	FVC is the volume of air exhaled with maximum effort and speed after a full inspiration. FVC is measured in a test known as spirometry, a type of pulmonary function test.	after intervention at 2 weeks
Secondary	Forced expiratory volume in one second(FEV1)	FEV1 is an individual test measure used to assess limitations in airflow, a type of pulmonary function test,which measures the amount of air exhaled in onesecond.	after intervention at 2 weeks
Secondary	Maximum mid expiratory flow(MMEF)	MMEF is forced expiratory flow between 25% and 75% of forced vital capacity,a type of pulmonary function test.	after intervention at 2 weeks
Secondary	Disease-free survival (DFS)	Time from randomization to first recurrence or metastasis	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
Secondary	TCM symptoms changes	TCM symptoms changes are according to the lung cancer symptom classification quantization table in "Guiding Principles for Clinical Research of Traditional Chinese Medicine in the Treatment of Lung Cancer (2002 Edition)"	after intervention at 3 months
Secondary	Tumor markers	Tumor markers include CEA, CA-125 and CYFRA21-1	after intervention at 3 months
Secondary	Safety assessment evaluated according to Common Toxicity Criteria	Safety assessment is evaluated according to Common Toxicity Criteria (CTC 3.0)	after intervention at 3 months