Efficacy Study of Comprehensive Rehabilitation Program in Postoperative NSCLC Patients

NCT ID: NCT03244605

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2019-12-30

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rehabilitation training plus TCM

Rehabilitation training include aerobic exercise training and Liu Zi Jue lung exercises, which will be started in one month after operation.

Prescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin 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.The patient will take TCM granules for 3 months.

Group Type: EXPERIMENTAL

Rehabilitation Training

Intervention Type: OTHER

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.

TCM

Intervention Type: DRUG

three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.

Rehabilitation education plus placebo

Patients who received rehabilitation education will not accept rehabilitation training.

We compromise the raw materials for the placebo including food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages.

The patient will take placebo granules for 3 months.

Group Type: PLACEBO_COMPARATOR

Rehabilitation Education

Intervention Type: OTHER

General health education

placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: OTHER

Rehabilitation Education

General health education

Intervention Type: OTHER

TCM

three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

aerobic exercise training; Liu Zi Jue lung exercises; health education; Prescriptions from Professor Xu Ling; control

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: collaborator

Shanghai Cancer Hospital, China

OTHER

Sponsor Role: collaborator

Huadong Hospital

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ling Xu, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai University of Traditional Chinese Medicine

Locations

YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35774470 (View on PubMed)

Other Identifiers

SHUTCM001

Identifier Type: -

Identifier Source: org_study_id