A Multicenter Real World Study of Kanglaite for Cancer Cachexia

Study Overview
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Brief Summary
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A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia

Detailed Description
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This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.

Official Title
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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

Conditions
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Cancer Cachexia

Intervention / Treatment
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* Drug: Kanglaite Injection/Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kanglaite Injection/Capsules<br>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 | Drug: Kanglaite Injection/Capsules<br>* 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<br>* Other names: Coix seed oil triglyceride, 03004812Z;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 2018 - 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass | Lean body mass | 2018 - 2020 | 
| Body weight | Body weight | 2018 - 2020 | 
| Grade of cachexia | Grade of cachexia | 2018 - 2020 | 
| European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30: 30 items, including functioning, symptoms, and overall health. min: 0, max: 100. The higher values indicate higher level of functioning and quality of life | 2018 - 2020 | 
| Karnofsky performance status | Karnofsky performance status | 2018 - 2020 | 
| Patient-generated subjective global assessment (PG-SGA) | Patient-generated subjective global assessment (PG-SGA) | 2018 - 2020 | 
| Numeric rating scale for pain | Numeric rating scale for pain min: 0; max: 10. The higher values indicate worse pain. | 2018 - 2020 | 
| Numeric rating scale for appetite | Numeric rating scale for appetite min: 0; max: 10. The higher values indicate worse appetite | 2018 - 2020 | 
| Synergistic antitumor effect: Overall response rate | Synergistic antitumor effect: Overall response rate | 2018 - 2020 | 
| Synergistic antitumor effect: Disease control rate | Synergistic antitumor effect: Disease control rate | 2018 - 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kanglaita Injection/Capsule, Cancer cachexia, Real-world evidences, Overall survival