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A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02553187
Recruitment Status : Unknown
Verified February 2017 by Zhejiang Kanglaite Pharmaceutical Co.Ltd.
Recruitment status was:  Recruiting
First Posted : September 17, 2015
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
H & J CRO International, Inc.
Information provided by (Responsible Party):
Zhejiang Kanglaite Pharmaceutical Co.Ltd

Tracking Information
First Submitted Date  ICMJE September 9, 2015
First Posted Date  ICMJE September 17, 2015
Last Update Posted Date February 15, 2017
Actual Study Start Date  ICMJE September 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
  • Body weight [ Time Frame: 77days ]
  • Lean body mass [ Time Frame: 77days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
  • Progression-free survival rate (PFS) [ Time Frame: 77days ]
  • Eastern Cooperative Oncology Group score (ECOG) [ Time Frame: 77days ]
  • Quality of life score (QOL) [ Time Frame: 77days ]
  • Survival curve [ Time Frame: 77days ]
  • Overall Survival (OS) [ Time Frame: 77days ]
  • Body Mass Index (BMI) [ Time Frame: 77days ]
  • Serum albumin [ Time Frame: 77days ]
  • Serum Prealbumin [ Time Frame: 77days ]
  • Serum Lactic Acid [ Time Frame: 77days ]
  • Incidence of myelosuppression (%) [ Time Frame: 77days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia
Official Title  ICMJE A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia
Brief Summary The purpose of the study is to explore the efficacy and safety of Kanglaite Injection in the treatment of patients with late-stage cancer cachexia.
Detailed Description The study is a multicenter, prospective, randomized controlled study. The planned sample size is 160 subjects. These subjects will be randomized (1:1) to treatment group (i.e., standard therapy plus Kanglaite Injection) or control group (i.e., standard therapy plus blank control). The study population includes the patients with non small cell lung cancer (adenocarcinoma), colorectal carcinoma and pancreatic carcinoma, who are complicated with cachexia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer Cachexia
Intervention  ICMJE Drug: Kanglaite Injection

200 mL, slow IV drip, once daily for 14 consecutive days, subsequent courses repeated after a 7-day interval.

Subjects will be treated for 4 courses (12 weeks).

Other Name: Coicis Oil injection
Study Arms  ICMJE
  • Experimental: Treatment group
    Kanglaite Injection plus standard therapy.
    Intervention: Drug: Kanglaite Injection
  • No Intervention: Control group
    Blank control and standard therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 16, 2015)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed patients with stage III-IV non-small cell lung cancer (adenocarcinoma), colorectal carcinoma or pancreatic carcinoma, who are not eligible for surgery, interventional treatment and radiation therapy;
  2. Confirmed patients with cachexia: weight loss greater than 5% in last six months, or BMI<20kg/m2 and weight loss greater than 2%, or in accordance with the diagnosis of sarcopenia and weight loss greater than 2%;
  3. Patients who are not being treated with chemotherapy should have completed chemotherapy 14 days before randomization of this study;
  4. For patients who are being treated with chemotherapy, the chemotherapy regimen should be confined to the regimens specified in the protocol; and the chemotherapy regimen, in general, are not allowed to be changed during the study period;
  5. Patients are conscious and able to cooperate with the doctor to complete the disease-related examinations and evaluations;
  6. ECOG performance status (PS) 0-3 for those who are not treated with chemotherapy; and ECOG PS 0-2 for those who are being treated with chemotherapy;
  7. Expected survival period is more than 4 months;
  8. Male or female aged 18 - 75 years;
  9. Patients who are willing to participate in the study and sign the informed consent form.

Exclusion Criteria:

  1. Any pathological type of non-small cell lung cancer (NSCLC) except adenocarcinoma;
  2. Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol;
  3. Patients with cachexia caused by other reasons, e.g. severe hepatic dysfunction [Aspartate transaminase(AST)/Cerealthirdtransaminase(ALT) >5 times the ULN], severe renal dysfunction (Cr >1.5 times the ULN), uncontrolled thyroid disease, New York Heart Association (NYHA) class III-IV heart failure, AIDS etc.;
  4. Any condition that may hinder the subject's completion of the study, including but not limited to severe uncontrollable organic diseases or infection, unstable angina pectoris, congestive heart failure, etc.;
  5. Patients who are being treated with other anticancer traditional Chinese medicine (TCM), or those who may be treated with TCM after enrollment;
  6. Patients with severe hepatic dysfunction: Scr >=1.5 times the ULN, ALT/AST/alkaline phosphatase (ALP) >=5 times the ULN, total bilirubin (TBIL) >=1.5 times the ULN;
  7. Patients with severe abnormal lipid metabolism [TC>300mg/dl or Triglyceride(TG) >2.5 times the ULN], or those who are in lipid-lowering therapy;
  8. Known or suspected diagnosis of metastatic encephaloma;
  9. In treatment of or plan to receive treatment of molecular targeted drugs, eg,epidermal growth factor receptor

    - tyrosine kinase inhibitor (EGFR-TKI), anaplastic lymphoma kinase (ALK) inhibitor, anti-angiogenic agents (including monoclonal antibodies and endostatin), and cetuximab;

  10. Patients present with an ECOG score>2 and require treatment of chemotherapy;
  11. Patients with allergies or intolerability to the investigational product or its excipients;
  12. Patients who are currently included in other clinical trials on antineoplastic drugs;
  13. Patients who are not able to provide the Informed Consent Form (ICF);
  14. Expected survival period is less than 4 months;
  15. Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception (including males);
  16. Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder;
  17. Any condition, in the investigator's opinion, is not in the best interest of the subject (e.g., harming the subject's health) or potentially interferes with the evaluation of treatment according to this protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02553187
Other Study ID Numbers  ICMJE KLT201401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhejiang Kanglaite Pharmaceutical Co.Ltd
Study Sponsor  ICMJE Zhejiang Kanglaite Pharmaceutical Co.Ltd
Collaborators  ICMJE H & J CRO International, Inc.
Investigators  ICMJE
Principal Investigator: Shiying YU Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
PRS Account Zhejiang Kanglaite Pharmaceutical Co.Ltd
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP