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

NCT03372694 | Unknown Phase 3 DMC

• 1 other identifier: SHUTCM002
• Study Type: interventional
• Target: 354
• 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 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.

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 QuestionnaireLung Cancer 43 (EORTC QLQ-LC43).

  Time Frame: baseline, at 4 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 (3)

Chemotherapy+Training+TCM

EXPERIMENTAL

Adjuvant Chemotherapy is performed within 6 weeks after operation. Rehabilitation training is mainly composed of gymnastic qigong, 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 four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.

Behavioral: Rehabilitation Training; Drug: TCM

Chemotherapy+Education+TCM

EXPERIMENTAL

Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training. Prescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.

Drug: TCM; Other: Rehabilitation Education

Chemotherapy+Education+Placebo

PLACEBO COMPARATOR

Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training. 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 BEHAVIORAL

Patients will be trained in one month after operation. Rehabilitation training will be carried out between every two cycles of chemotherapy. Rehabilitation training is mainly composed of gymnastics qigong, which has long been regarded as a form of rehabilitation in Traditonal Chinese Medicine. According to the poor pulmonary function of patients with lung cancer after operation, Liu Zi Jue lung exercise is chosen to strengthen the pulmonary function of the human body in Chinese traditional health culture. Liu Zi Jue lung exercise intervention will be lead by an expert instructor, five times a week, 15 min/time.

Also known as: gymnastics qigong, Liu Zi Jue lung exercises

Chemotherapy+Training+TCM

TCM DRUG

four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach 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.

Also known as: Prescriptions from Professor Xu Ling

Chemotherapy+Education+TCM; Chemotherapy+Training+TCM

Rehabilitation Education OTHER

General health education

Also known as: health education

Chemotherapy+Education+Placebo; Chemotherapy+Education+TCM

placebo DRUG

four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe and detoxication and resolving masses recipe，with the same color, smell，taste, weight and package

Also known as: control

Chemotherapy+Education+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:

• 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

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 (2)

• Zhang YL, Jiao LJ, Gong YB, Xu JF, Ni J, Shen XY, Zhang J, Zhou D, Qian CX, Wang Q, Yao JL, Yang WX, Su LZ, Wang LY, Li JQ, Yao YQ, Zhang YH, Wang YC, Chen ZW, Xu L. Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2024 Nov;30(11):963-973. doi: 10.1007/s11655-024-4114-9. Epub 2024 Sep 12.

  PMID: 39266862 DERIVED

• Yao J, Jiao L, Yao Y, Lu Y, Shi J, Li J, Chen P, Xu L, Gong Y. The effect of comprehensive rehabilitation program plus chemotherapy on quality of life in patients with postoperative non-small-cell lung cancer: study protocol of a multicenter randomized clinical trial. Trials. 2020 Apr 3;21(1):309. doi: 10.1186/s13063-020-4162-1.

  PMID: 32245480 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 14, 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

Locations

CN (1)