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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. 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
H & J CRO International, Inc.
Information provided by (Responsible Party):
Zhejiang Kanglaite Pharmaceutical Co.Ltd

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.

Condition or disease Intervention/treatment Phase
Cancer Cachexia Drug: Kanglaite Injection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia
Actual Study Start Date : September 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Treatment group
Kanglaite Injection plus standard therapy.
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

No Intervention: Control group
Blank control and standard therapy.

Primary Outcome Measures :
  1. Body weight [ Time Frame: 77days ]
  2. Lean body mass [ Time Frame: 77days ]

Secondary Outcome Measures :
  1. Progression-free survival rate (PFS) [ Time Frame: 77days ]
  2. Eastern Cooperative Oncology Group score (ECOG) [ Time Frame: 77days ]
  3. Quality of life score (QOL) [ Time Frame: 77days ]
  4. Survival curve [ Time Frame: 77days ]
  5. Overall Survival (OS) [ Time Frame: 77days ]
  6. Body Mass Index (BMI) [ Time Frame: 77days ]
  7. Serum albumin [ Time Frame: 77days ]
  8. Serum Prealbumin [ Time Frame: 77days ]
  9. Serum Lactic Acid [ Time Frame: 77days ]
  10. Incidence of myelosuppression (%) [ Time Frame: 77days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02553187

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Contact: Shiying YU +8613871382805
Contact: li Zhang +8613554191436

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China, Hubei
Cancer Center, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Shiying Yu    +8613871382805      
Sponsors and Collaborators
Zhejiang Kanglaite Pharmaceutical Co.Ltd
H & J CRO International, Inc.
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Principal Investigator: Shiying YU Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

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Responsible Party: Zhejiang Kanglaite Pharmaceutical Co.Ltd Identifier: NCT02553187    
Other Study ID Numbers: KLT201401
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders