A Multicenter Real World Study of Kanglaite for Cancer Cachexia

Sponsor

Zhejiang Kanglaite Pharmaceutical Co.Ltd (Other)

Overall Status

Unknown status

CT.gov ID

NCT03631459

Collaborator

NanJing PLA 81 Hospital (Other), LinkDoc Technology (Beijing) Co. Ltd. (Industry)

100,000

Enrollment

Locations

Anticipated Duration (Months)

50000

Patients Per Site

2174.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer Cachexia	Drug: Kanglaite Injection/Capsules

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 20, 2018

Anticipated Primary Completion Date :

Mar 20, 2020

Anticipated Study Completion Date :

Jul 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Kanglaite Injection/Capsules 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 Other Names: Coicis oil injection, Z10970091 Coix seed oil triglyceride, 03004812Z

Arm

Intervention/Treatment

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

Drug: Kanglaite Injection/Capsules

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

Other Names:

Coicis oil injection, Z10970091

Coix seed oil triglyceride, 03004812Z

Outcome Measures

Primary Outcome Measures

Overall survival [2018 - 2020]
Overall survival

Secondary Outcome Measures

Lean body mass [2018 - 2020]
Lean body mass
Body weight [2018 - 2020]
Body weight
Grade of cachexia [2018 - 2020]
Grade of cachexia
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 [2018 - 2020]
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
Karnofsky performance status [2018 - 2020]
Karnofsky performance status
Patient-generated subjective global assessment (PG-SGA) [2018 - 2020]
Patient-generated subjective global assessment (PG-SGA)
Numeric rating scale for pain [2018 - 2020]
Numeric rating scale for pain min: 0; max: 10. The higher values indicate worse pain.
Numeric rating scale for appetite [2018 - 2020]
Numeric rating scale for appetite min: 0; max: 10. The higher values indicate worse appetite
Synergistic antitumor effect: Overall response rate [2018 - 2020]
Synergistic antitumor effect: Overall response rate
Synergistic antitumor effect: Disease control rate [2018 - 2020]
Synergistic antitumor effect: Disease control rate

Other Outcome Measures

Adverse events [2018 - 2020]
Adverse events
Serious adverse event [2018 - 2020]
Serious adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.