Trial record 3 of 32 for:    "traditional chinese medicine" and cancer | Open Studies

Clinical Study of Chemotherapy Combined With Chinese Medicine on Survival Affect of Elderly Patients With Lung Cancer

This study is not yet open for participant recruitment.
Verified May 2013 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Shanghai Chest Hospital
Fudan University
Information provided by (Responsible Party):
Zhiyi Zhou, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01780181
First received: January 29, 2013
Last updated: May 25, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to observe the efficacy of chemotherapy combined with Traditional Chinese Medicine for elderly patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.


Condition Intervention
Cancer
Drug: TCM
Drug: Chemotherapy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Randomized Double-blind Controlled Clinical Study of Chemotherapy Combined With or Without Traditional Chinese Medicine on Survival Affect of Elderly Patients With Advanced Non-small-cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Progression-free survival(PFS) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Objective response rate [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Time-to-Progression(TTP) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • quality of life(QOL) [ Time Frame: one cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 76
Study Start Date: July 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TCM plus chemotherapy
TCM:oral granules,YangYinFang or YiQiFang or YiQiYangYinFang, four packages,twice a day, three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo;
Drug: TCM
TCM: In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang 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.The herbal treatment is adapted to the syndromes.
Other Names:
  • YangYinFang:four packages twice a day
  • YiQiFang :four packages twice a day
  • YiQiYangYinFang:four packages twice a day
Drug: Chemotherapy
treated with single-agent chemotherapy :DOC、NVB、GEM DOC 60mg/m2 d1 Q3W NVB 30mg/m2 d1,d8 Q3W GEM 1200mg/m2 d1,d8 Q3W
Other Names:
  • treated with single-agent chemotherapy :
  • DOC:Docetaxel
  • NVB:Vinorelbine
  • GEM:Gemcitabine
Placebo plus chemotherapy
TCM Placebo: oral granules,YangYinFang orYiQiFang or YiQiYangYinFang, 10% of the original dose,four packages,twice a day ,three months; Chemotherapy : Intravenous drug use, treated with single-agent chemotherapy :DOC、NVB、GEM.Each cycle was 21-days. Cycles were repeated until disease progression, unacceptable toxicity, or chemotherapy taboo;
Drug: Chemotherapy
treated with single-agent chemotherapy :DOC、NVB、GEM DOC 60mg/m2 d1 Q3W NVB 30mg/m2 d1,d8 Q3W GEM 1200mg/m2 d1,d8 Q3W
Other Names:
  • treated with single-agent chemotherapy :
  • DOC:Docetaxel
  • NVB:Vinorelbine
  • GEM:Gemcitabine

Detailed Description:

Non-small-cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer diagnoses and more than 75% of the patients are diagnosed with an advanced stage. ASCO guidelines recommended that elderly patients with advanced NSCLC use single-agent chemotherapy. Nearly a decade of clinical trials showed that:the median survival time (MST) of Vinorelbine is 5-10months,1-year survival rate is 32%;the MST of Gemcitabine is 6.8-9months,the MST of Taxol is 6.8-10.3months.Research had shown that TCM can prolong long-term survival and improve QOL, but high-level evidence is desperately needed to support this finding.

The investigators perform a multi-center, randomized, double-blind controlled, prospective study in elderly patients with advanced NSCLC. Patients are randomized over observational group (TCM granules plus single-agent chemotherapy), and control group (TCM placebo plus single-agent chemotherapy). The investigators will observe 4 cycles and after that regular follow-up will be arranged. The primary end point is: PFS (progression-free survival); the secondary end points are: (1) OS(overall survival); (2) Objective response rate; (3) TTP(Time-to-Progression); (4) QOL (EORTC QLQ-L43, TCM syndrome score); (5) other end points are: Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with chemotherapy has a better efficacy on prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of chemotherapy.Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pathologically or cytologically confirmed of stage IIIb-IV NSCLC; Ages Eligible for Study: ≥65 years old; TCM syndromes are deficiency of Yin, deficiency of Qi and deficiency of both Qi and Yin.

Criteria

Inclusion Criteria:

  1. Pathologically or cytologically confirmed of stage IIIb-IV NSCLC ;
  2. Ages Eligible for Study: ≥65 years old;
  3. Physical status score (ECOG PS) ≤ 2 scores;
  4. Estimated life expectancy of at least 12 weeks;
  5. Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥9g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100 *109/L,bilirubin≤1.5ULN,alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range(1.2DLN-1.2ULN),creatinine≤1.5ULN;
  6. Informed consent from the patient.

Exclusion Criteria:

  1. Patient with other malignant tumor except NSCLC 5 years previous to study entry.
  2. Patients who have received single-agent chemotherapy treatment;
  3. Estimated life expectancy less than 12 weeks;
  4. Serious problem of heart, liver or kidney with severe dysfunction;
  5. Pregnant or child breast feeding women;
  6. Mental or cognitive disorders;
  7. Participating in other drug trials;
  8. Who are allergic to the study drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780181

Contacts
Contact: Zhiyi Zhou, CMD, PhD 8621-64385700-3822 zhouzhiyi77@hotmail.com

Locations
China, Shanghai
Zhiyi Zhou Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhiyi Zhou, CMD, PhD    +8613661707859    zhouzhiyi77@hotmail.com   
Principal Investigator: Zhiyi Zhou, CMD, PhD         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Shanghai Chest Hospital
Fudan University
Investigators
Principal Investigator: Zhiyi Zhou, CMD, PhD Longhua Hospital Affiliated to Shanghai University of TCM
  More Information

No publications provided

Responsible Party: Zhiyi Zhou, Longhua Hospital, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01780181     History of Changes
Other Study ID Numbers: 12401905700zzy
Study First Received: January 29, 2013
Last Updated: May 25, 2013
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai University of Traditional Chinese Medicine:
lung cancer
traditional Chinese medicine

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014