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Efficacy Study of Comprehensive Rehabilitation Program in Postoperative NSCLC Patients

NCT03244605 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2019-06-12

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

OTHER

Rehabilitation Education

General health education

DRUG

TCM

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

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

Sponsors & Collaborators

  • Shanghai Chest Hospital

    collaborator OTHER

  • Shanghai Pulmonary Hospital, Shanghai, China

    collaborator OTHER

  • Shanghai Cancer Hospital, China

    collaborator OTHER

  • Huadong Hospital

    collaborator OTHER

  • Shanghai University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Ling Xu, MD & PhD · Shanghai University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2019-09-30
Completion
2019-12-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244605 on ClinicalTrials.gov