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

Shanghai University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Behavioral: Rehabilitation Training; Other: Rehabilitation Education; Drug: placebo; Drug: TCM

Study type: Interventional

Funder types: Other

Identifiers

NCT03372694

SHUTCM002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 354 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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354 participants in 3 patient groups, including a placebo group

Chemotherapy+Training+TCM

Experimental group

Description:

Adjuvant Chemotherapy is performed within 6 weeks after operation. Rehabilitation training is mainly composed of gymnastic qigong, 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 four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.

Treatment:

Drug: TCM

Behavioral: Rehabilitation Training

Chemotherapy+Education+TCM

Experimental group

Description:

Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training. Prescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.

Treatment:

Drug: TCM

Other: Rehabilitation Education

Chemotherapy+Education+Placebo

Placebo Comparator group

Description:

Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training. 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.

Treatment:

Drug: placebo

Other: Rehabilitation Education