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

NCT01780181 | Completed

• 1 other identifier: 12401905700zzy
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

lung cancer; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Progression-free survival（PFS）

  2 months

Secondary Outcomes (4)

• overall survival

  2 months

• Objective response rate

  2 months

• Time-to-Progression(TTP)

  2 months

• quality of life(QOL)

  one cycle

Study Arms (2)

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; Drug: Chemotherapy

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

Interventions

TCM DRUG

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.

Also known as: YangYinFang:four packages twice a day, YiQiFang :four packages twice a day, YiQiYangYinFang:four packages twice a day

TCM plus chemotherapy

Chemotherapy DRUG

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

Also known as: treated with single-agent chemotherapy :, DOC：Docetaxel, NVB：Vinorelbine, GEM：Gemcitabine

Placebo plus chemotherapy; TCM plus chemotherapy

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Pathologically or cytologically confirmed of stage IIIb-IV NSCLC ;
• Ages Eligible for Study: ≥65 years old;
• Physical status score (ECOG PS) ≤ 2 scores;
• Estimated life expectancy of at least 12 weeks;
• 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;
• Informed consent from the patient.

You may not qualify if:

• Patient with other malignant tumor except NSCLC 5 years previous to study entry.
• Patients who have received single-agent chemotherapy treatment；
• Estimated life expectancy less than 12 weeks;
• Serious problem of heart, liver or kidney with severe dysfunction;
• Pregnant or child breast feeding women;
• Mental or cognitive disorders;
• Participating in other drug trials;
• Who are allergic to the study drug.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Chest Hospital: collaborator
• Fudan University: collaborator

Study Sites (1)

Zhiyi Zhou

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Zhou ZY, Xu L, Li HG, Tian JH, Jiao LJ, You SF, Han ZF, Jiang Y, Guo HR, Liu H. Chemotherapy in conjunction with traditional Chinese medicine for survival of elderly patients with advanced non-small-cell lung cancer: protocol for a randomized double-blind controlled trial. J Integr Med. 2014 May;12(3):175-81. doi: 10.1016/S2095-4964(14)60028-5.

  PMID: 24861837 DERIVED

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Interventions

Drug Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhiyi Zhou, CMD, PhD

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Longhua Hospital

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 30, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)