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

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Huadong Hospital; Shanghai Cancer Hospital, China; Shanghai Chest Hospital; Shanghai Pulmonary Hospital, Shanghai, China

Criteria

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;