Efficacy Study of Comprehensive Rehabilitation Program Plus Chemotherapy in Postoperative NSCLC Patients

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03372694
• Other study ID #: SHUTCM002
• 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 354
• 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:

• Patients with completely resected stage IB-IIIA non-small-cell lung cancer who will receive chemotherapy for the first time within 6 weeks after the operation.

• 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

Behavioral:
• Rehabilitation Training
Patients will be trained in one month after operation. Rehabilitation training will be carried out between every two cycles of chemotherapy. Rehabilitation training is mainly composed of gymnastics qigong, which has long been regarded as a form of rehabilitation in Traditonal Chinese Medicine. According to the poor pulmonary function of patients with lung cancer after operation, Liu Zi Jue lung exercise is chosen to strengthen the pulmonary function of the human body in Chinese traditional health culture. Liu Zi Jue lung exercise intervention will be lead by an expert instructor, five times a week, 15 min/time.

Drug:
• TCM
four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe and detoxication and resolving masses recipe. Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.

Other:
• Rehabilitation Education
General health education

Drug:
• placebo
four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach 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 QuestionnaireLung Cancer 43 (EORTC QLQ-LC43).	Time Frame: baseline, at 4 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 4 months
Secondary	Tumor markers	Tumor markers include CEA, CA-125 and CYFRA21-1	after intervention at 4 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 4 months