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Non-small Cell Lung CancerPhase 3NCT03372694

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

A Phase 3 study testing Rehabilitation Training, TCM and Rehabilitation Education in people with Non-small Cell Lung Cancer, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Rehabilitation Training, TCM and Rehabilitation Education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
354 participants
Where
1 siteChina
Study dates
1 Oct 2016to 30 Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shanghai, Shanghai Municipality, 200437

Other trials in China

About this study

Official title: Clinical Study on the Effect of Comprehensive Rehabilitation Program Plus Chemotherapy Versus Chemotherapy on Quality of Life in Postoperative Non Small Cell Lung Cancer Patients With Stage IB-IIIA

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.

Read the detailed description

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 high risk stages IB to IIIA may undergo radical surgery and complete 4-6 cycles of adjuvant chemotherapy. 5 year survival rate increased from 43.5% to 48.8%, but some patients will end chemotherapy because of the side effects of chemotherapy. Comprehensive rehabilitation program may alleviate the side effects 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 plus chemotherapy to improve quality of life(QOL) and long-term survival of postoperative patients who need complete postoperative chemotherapy with high risk stages IB to IIIA. Patients are randomized into A observational group (chemotherapy plus rehabilitation training and TCM), B observational group(chemotherapy plus rehabilitation education and TCM) and control group (chemotherapy plus rehabilitation education and 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 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.

Being tested
Rehabilitation Training, TCM, Rehabilitation Education, placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabilitation TrainingBehavioural

    Also called gymnastics qigong, Liu Zi Jue lung exercises

    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.

  • TCMDrug

    Also called Prescriptions from Professor Xu Ling

    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.

  • Rehabilitation EducationOther

    Also called health education

    General health education

  • placeboDrug

    Also called control

    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

Study groups in NCT03372694
Study groupRoleWhat they receive
Chemotherapy+Training+TCMExperimentalAdjuvant 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.
Receives: Behavioral: Rehabilitation Training; Drug: TCM
Chemotherapy+Education+TCMExperimentalAdjuvant 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.
Receives: Drug: TCM; Other: Rehabilitation Education
Chemotherapy+Education+PlaceboPlacebo comparatorAdjuvant 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.
Receives: Other: Rehabilitation Education; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Time Frame: baseline, at 4 months

Secondary outcomes (9)

  1. Residual capacity (RV)

    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.

    Measured: after intervention at 2 weeks

  2. Total lung capacity（TLC）

    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.

    Measured: after intervention at 2 weeks

  3. Forced vital capacity (FVC)

    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.

    Measured: after intervention at 2 weeks

  4. Forced expiratory volume in one second(FEV1)

    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.

    Measured: after intervention at 2 weeks

  5. Maximum mid expiratory flow(MMEF)

    MMEF is forced expiratory flow between 25% and 75% of forced vital capacity,a type of pulmonary function test.

    Measured: after intervention at 2 weeks

  6. Disease-free survival (DFS)

    Time from randomization to first recurrence or metastasis

    Measured: 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

  7. TCM symptoms changes

    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)"

    Measured: after intervention at 4 months

  8. Tumor markers

    Tumor markers include CEA, CA-125 and CYFRA21-1

    Measured: after intervention at 4 months

  9. Safety assessment evaluated according to Common Toxicity Criteria

    Safety assessment is evaluated according to Common Toxicity Criteria (CTC 3.0)

    Measured: after intervention at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2017
  2. Study start1 Oct 2016
  3. Primary completion30 Sep 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
354 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03372694
Sponsor's protocol ID
SHUTCM002
Status last verified
Apr 2019
First submitted
10 Dec 2017
Last updated
12 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39266862

  • 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.

    PubMed 32245480

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rehabilitation Training, TCM and Rehabilitation Education in people with Non-small Cell Lung Cancer, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Quality of life (QOL) (time frame: Time Frame: baseline, at 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03372694, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.

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