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

NCT02553187 | Unknown Phase 4 DMC

• 1 other identifier: KLT201401
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Cachexia

Outcome Measures

Primary Outcomes (2)

• Body weight

  77days

• Lean body mass

  77days

Secondary Outcomes (10)

• Progression-free survival rate (PFS)

  77days

• Eastern Cooperative Oncology Group score (ECOG)

  77days

• Quality of life score (QOL)

  77days

• Survival curve

  77days

• Overall Survival (OS)

  77days

Study Arms (2)

Treatment group

EXPERIMENTAL

Kanglaite Injection plus standard therapy.

Drug: Kanglaite Injection

Control group

NO INTERVENTION

Blank control and standard therapy.

Interventions

Kanglaite Injection DRUG

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).

Also known as: Coicis Oil injection

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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%;
• Patients who are not being treated with chemotherapy should have completed chemotherapy 14 days before randomization of this study;
• 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;
• Patients are conscious and able to cooperate with the doctor to complete the disease-related examinations and evaluations;
• 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;
• Expected survival period is more than 4 months;
• Male or female aged 18 - 75 years;
• Patients who are willing to participate in the study and sign the informed consent form.

You may not qualify if:

• Any pathological type of non-small cell lung cancer (NSCLC) except adenocarcinoma;
• Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol;
• 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.;
• 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.;
• Patients who are being treated with other anticancer traditional Chinese medicine (TCM), or those who may be treated with TCM after enrollment;
• 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;
• 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;
• Known or suspected diagnosis of metastatic encephaloma;
• 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;
• Patients present with an ECOG score\>2 and require treatment of chemotherapy;
• Patients with allergies or intolerability to the investigational product or its excipients;
• Patients who are currently included in other clinical trials on antineoplastic drugs;
• Patients who are not able to provide the Informed Consent Form (ICF);
• Expected survival period is less than 4 months;

Sponsors & Collaborators

• Zhejiang Kanglaite Pharmaceutical Co.Ltd: lead
• H & J CRO International, Inc.: collaborator

Study Sites (1)

Cancer Center, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

kang-lai-te

Study Officials

• Shiying YU

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiying YU

CONTACT

+8613871382805; syyu@tjh.tjmu.edu.cn

li Zhang

CONTACT

+8613554191436; luzigang@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

CN (1)