Efficacy Study of Comprehensive Rehabilitation Program 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 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.

• 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:

• 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;