Efficacy Study of Comprehensive Rehabilitation Program in Postoperative NSCLC Patients

June 11, 2019 updated by: Shanghai University of Traditional Chinese Medicine

Clinical Study on the Effect of Comprehensive Rehabilitation Program on Quality of Life and Long-term Survival in Postoperative Non Small Cell Lung Cancer Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200437
        • YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: TCM
three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.
Other Names:
  • Prescriptions from Professor Xu Ling
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 Names:
  • aerobic exercise training
  • Liu Zi Jue lung exercises
Placebo Comparator: 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.
Other: Rehabilitation Education
General health education
Other Names:
  • health education
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
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Quality of life (QOL)
Time Frame: baseline, at 3 months
QOL is assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 43 (EORTC QLQ-LC43).
baseline, at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Residual capacity (RV)
Time Frame: after intervention at 2 weeks
RV is measured in a test known as Lung valume(LV)spirometry,a type of pulmonary function test.RV is the volume of air remaining in the lungs after a maximal expiratory effort.
after intervention at 2 weeks
Total lung capacity（TLC）
Time Frame: after intervention at 2 weeks
TLC is measured in a test known as Lung valume(LV)spirometry,a type of pulmonary function test.TLC equals the vital capacity plus the residual capacity.
after intervention at 2 weeks
Forced vital capacity (FVC)
Time Frame: after intervention at 2 weeks
FVC is the volume of air exhaled with maximum effort and speed after a full inspiration. FVC is measured in a test known as spirometry, a type of pulmonary function test.
after intervention at 2 weeks
Forced expiratory volume in one second(FEV1)
Time Frame: after intervention at 2 weeks
FEV1 is an individual test measure used to assess limitations in airflow, a type of pulmonary function test,which measures the amount of air exhaled in onesecond.
after intervention at 2 weeks
Maximum mid expiratory flow(MMEF)
Time Frame: after intervention at 2 weeks
MMEF is forced expiratory flow between 25% and 75% of forced vital capacity,a type of pulmonary function test.
after intervention at 2 weeks
Disease-free survival (DFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Time from randomization to first recurrence or metastasis
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
TCM symptoms changes
Time Frame: after intervention at 3 months
TCM symptoms changes are according to the lung cancer symptom classification quantization table in "Guiding Principles for Clinical Research of Traditional Chinese Medicine in the Treatment of Lung Cancer (2002 Edition)"
after intervention at 3 months
Tumor markers
Time Frame: after intervention at 3 months
Tumor markers include CEA, CA-125 and CYFRA21-1
after intervention at 3 months
Safety assessment evaluated according to Common Toxicity Criteria
Time Frame: after intervention at 3 months
Safety assessment is evaluated according to Common Toxicity Criteria (CTC 3.0)
after intervention at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai University of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Chest Hospital
Shanghai Cancer Hospital, China
Shanghai Pulmonary Hospital, Shanghai, China
Huadong Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ling Xu, MD & PhD, Shanghai University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHUTCM001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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