Trial record 2 of 5 for:    kanglaite

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Zhejiang Kanglaite Pharmaceutical Co.Ltd
H&J CRO International, Inc.
Information provided by (Responsible Party):
Zhejiang Kanglaite Pharmaceutical Co.Ltd Identifier:
First received: September 9, 2015
Last updated: September 16, 2015
Last verified: September 2015
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 Intervention Phase
Cancer Cachexia
Drug: Kanglaite Injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia

Further study details as provided by Zhejiang Kanglaite Pharmaceutical Co.Ltd:

Primary Outcome Measures:
  • Body weight [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Lean body mass [ Time Frame: 77days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival rate (PFS) [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Eastern Cooperative Oncology Group score (ECOG) [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Quality of life score (QOL) [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Survival curve [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Serum albumin [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Serum Prealbumin [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Serum Lactic Acid [ Time Frame: 77days ] [ Designated as safety issue: No ]
  • Incidence of myelosuppression (%) [ Time Frame: 77days ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02553187

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

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.
Principal Investigator: Shiying YU Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: Zhejiang Kanglaite Pharmaceutical Co.Ltd Identifier: NCT02553187     History of Changes
Other Study ID Numbers: KLT201401
Study First Received: September 9, 2015
Last Updated: September 16, 2015
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms
Weight Loss processed this record on November 25, 2015