NCT01441752

Brief Summary

The investigators performed a multi-center, randomized, controlled, double-blind, prospective study on evaluating effect of chemotherapy combined with or without integrated TCM on quality of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with chemotherapy compared to that by chemotherapy alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

3.3 years

First QC Date

July 14, 2011

Last Update Submit

June 23, 2016

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • quality of life（QoL)

    every three weeks

Secondary Outcomes (1)

  • two-year disease-free survival rate and disease-free survival

    once every three months

Study Arms (2)

Chemotherapy + TCM group

EXPERIMENTAL

The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles. Prescriptions formulated into granules origin from Professor Liu Jiaxiang in Longhua 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.

Drug: TCM

Chemotherapy + placebo group

PLACEBO COMPARATOR

The chemotherapy for NSCLC patients is a combination of Vinorelbine, 25mg/m2, d1, 8 and DDP, 75mg/m2, d1 (NP) giving three-weekly for four cycles.we compromise the raw materials for the placebo including 10% of Chinese medicine, 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.

Drug: placebo

Interventions

TCMDRUG

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

Also known as: Prescriptions from Professor Liu Jiaxiang
Chemotherapy + TCM group
placeboDRUG

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

Chemotherapy + placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnostic criteria of primary bronchial lung cancer, and pathologically or cytologically confirmed of NSCLC (squamouscarcinoma, adenocarcinoma, adenosquamous carcinoma and large cell carcinoma) patients;
  • Age \> 18 years old;
  • TCM syndromes are Yin deficiency, Qi deficiency, deficiency of both Qi and Yin, deficiency of both Spleen and Kidney;
  • Physical status score (ECOG PS) ≤ 2 scores;
  • Stage Ib \~ Ⅲb with complete resection, chemotherapy is performed in 6 weeks after resection, including tumor size \> 2cm of stage Ia;
  • Blood routine: N \> 1.5×109/L、PLT \> 100×109/L, normal liver function and kidney function;
  • Voluntarily involved to clinical study and sign informed consent.

You may not qualify if:

  • Suffering from other primary malignant tumor in 5 years;
  • Incomplete resection or uncertain to take resection;
  • Serious disease of heart, liver, kidney with severe dysfunction;
  • Pregnancy or breast-feeding women;
  • Mental or cognitive disorders which would influence judgment of QOL in this study;
  • During or had adjuvant chemotherapy;
  • Being participating other drug trials;
  • Allergy to the drug in our study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ShanghaiUTCM

Shanghai, Shanghai Municipality, 200032, China

Location

Xuling

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (3)

  • Wang Y, Jiao L, Chen Z, Xu J, Che J, Huang H, Zhang L, Shen X, Yang Y, Zhao T, Zhang J, Zhou D, Wang Q, Yao J, Yang W, Sun C, Li J, Bi L, Ding R, Goodfellow I, Gong Y, Xu L. Adjuvant Chemotherapy with Traditional Chinese Herbal Granules Versus Placebo in Resected Non-Small Cell Lung Cancer: Updated Survival Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251409081. doi: 10.1177/15347354251409081. Epub 2026 Jan 27.

    PMID: 41589575DERIVED

  • Wang Q, Jiao L, Wang S, Chen P, Bi L, Zhou D, Yao J, Li J, Wang L, Chen Z, Jia Y, Zhang Z, Shen W, Zhu W, Xu J, Gao Y, Xu L, Gong Y. Adjuvant Chemotherapy with Chinese Herbal Medicine Formulas Versus Placebo in Patients with Lung Adenocarcinoma after Radical Surgery: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Biol Proced Online. 2020 Mar 1;22:5. doi: 10.1186/s12575-020-00117-5. eCollection 2020.

    PMID: 32140080DERIVED

  • Xu L, Li H, Xu Z, Wang Z, Liu L, Tian J, Sun J, Zhou L, Yao Y, Jiao L, Su W, Guo H, Chen P, Liu J. Multi-center randomized double-blind controlled clinical study of chemotherapy combined with or without traditional Chinese medicine on quality of life of postoperative non-small cell lung cancer patients. BMC Complement Altern Med. 2012 Aug 1;12:112. doi: 10.1186/1472-6882-12-112.

    PMID: 22853619DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • xu ling

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • xu ling, doctor

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
State Administration of Traditional Chinese Medicine of Shanghai

Study Record Dates

First Submitted

July 14, 2011

First Posted

September 28, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

CN(2)