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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Zhejiang Kanglaite Pharmaceutical Co.Ltd

Current Primary Outcome:

  • Body weight [ Time Frame: 77days ]
  • Lean body mass [ Time Frame: 77days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Zhejiang Kanglaite Pharmaceutical Co.Ltd

Dates:
Date Received: September 9, 2015
Date Started: September 2015
Date Completion: July 2018
Last Updated: February 14, 2017
Last Verified: February 2017