A Multicenter Real World Study of Kanglaite for Cancer Cachexia
Safety and Effectiveness of Kanglaite Injection/Capsules for Treatment of Cancer Cachexia: A Prospective, Multicenter Real World Study of a Large Cohort of Chinese Patients
1 other identifier
observational
100,000
1 country
2
Brief Summary
A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
August 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2020
CompletedAugust 21, 2018
August 1, 2018
1.6 years
August 12, 2018
August 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival
2018 - 2020
Secondary Outcomes (10)
Lean body mass
2018 - 2020
Body weight
2018 - 2020
Grade of cachexia
2018 - 2020
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30
2018 - 2020
Karnofsky performance status
2018 - 2020
- +5 more secondary outcomes
Other Outcomes (2)
Adverse events
2018 - 2020
Serious adverse event
2018 - 2020
Study Arms (1)
Kanglaite Injection/Capsules
Kanglaite injection 200ml, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles
Interventions
Kanglaite injection 200 mL, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles
Eligibility Criteria
Patients meeting international diagnostic criteria for cachexia: 1. Weight loss \> 5% over past 6 months or 2. BMI\<20 kg/m2 and weight loss \> 2% or 3. Sarcopenia and weight loss \>2%;
You may qualify if:
- Patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Kanglaite Pharmaceutical Co.Ltdlead
- NanJing PLA 81 Hospitalcollaborator
- LinkDoc Technology (Beijing) Co. Ltd.collaborator
Study Sites (2)
Peking University International Hospital
Beijing, Beijing Municipality, 102206, China
NanJing PLA 81 Hospital
Nanjing, Jiangsu, 210002, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shukui Qin, MD
NanJing PLA 81 Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2018
First Posted
August 15, 2018
Study Start
August 20, 2018
Primary Completion
March 20, 2020
Study Completion
July 20, 2020
Last Updated
August 21, 2018
Record last verified: 2018-08