A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia
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|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
|Condition or disease||Intervention/treatment||Phase|
|Cancer Cachexia||Drug: Kanglaite Injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Body weight [ Time Frame: 77days ]
- Lean body mass [ Time Frame: 77days ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT02553187
|Contact: Shiying YUemail@example.com|
|Contact: li Zhangfirstname.lastname@example.org|
|Cancer Center, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology||Recruiting|
|Wuhan, Hubei, China, 430030|
|Contact: Shiying Yu +8613871382805|
|Principal Investigator:||Shiying YU||Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology|