Efficacy Study of Comprehensive Rehabilitation Program in Postoperative NSCLC Patients

NCT03244605 | Unknown Phase 3 DMC

• 1 other identifier: SHUTCM001
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Quality of life (QOL)

  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 Outcomes (9)

• Residual capacity (RV)

  after intervention at 2 weeks

• Total lung capacity（TLC）

  after intervention at 2 weeks

• Forced vital capacity (FVC)

  after intervention at 2 weeks

• Forced expiratory volume in one second(FEV1)

  after intervention at 2 weeks

• Maximum mid expiratory flow(MMEF)

  after intervention at 2 weeks

Study Arms (2)

Rehabilitation training plus TCM

EXPERIMENTAL

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.

Other: Rehabilitation Training; Drug: TCM

Rehabilitation education plus placebo

PLACEBO COMPARATOR

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; Drug: placebo

Interventions

Rehabilitation Training OTHER

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.

Also known as: aerobic exercise training, Liu Zi Jue lung exercises

Rehabilitation training plus TCM

Rehabilitation Education OTHER

General health education

Also known as: health education

Rehabilitation education plus placebo

TCM DRUG

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

Also known as: Prescriptions from Professor Xu Ling

Rehabilitation training plus TCM

placebo DRUG

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

Also known as: control

Rehabilitation education plus placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Chest Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Shanghai Cancer Hospital, China: collaborator
• Huadong Hospital: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200437, China

Location

Related Publications (1)

• Qin X, Bi L, Yang W, He Y, Gu Y, Yang Y, Gong Y, Wang Y, Yan X, Xu L, Xiao H, Jiao L. Dysbiosis of the Gut Microbiome Is Associated With Histopathology of Lung Cancer. Front Microbiol. 2022 Jun 14;13:918823. doi: 10.3389/fmicb.2022.918823. eCollection 2022.

  PMID: 35774470 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ling Xu, MD & PhD

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: August 9, 2017
• Study Start: October 1, 2016
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)