A Multicenter Real World Study of Kanglaite for Cancer Cachexia

• Conditions: Cancer Cachexia
• Interventions: Drug: Kanglaite Injection/Capsules

• Registration Number: NCT03631459
• Lead Sponsor: Zhejiang Kanglaite Pharmaceutical Co.Ltd

Brief Summary

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

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 Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-12
• Study First Submitted QC: 2018-08-12
• Study First Posted: 2018-08-15
• Last Update Submitted: 2018-08-17
• Study Start: 2018-08-20
• Last Update Posted: 2018-08-21
• Primary Completion: 2020-03-20
• Study Completion: 2020-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kanglaite Injection/Capsules	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

Primary Outcome Measures

Name	Time	Method
Overall survival	2018 - 2020	Overall survival

Secondary Outcome Measures

Name	Time	Method
Body weight	2018 - 2020	Body weight
Patient-generated subjective global assessment (PG-SGA)	2018 - 2020	Patient-generated subjective global assessment (PG-SGA)
Lean body mass	2018 - 2020	Lean body mass
Grade of cachexia	2018 - 2020	Grade of cachexia
Numeric rating scale for appetite	2018 - 2020	Numeric rating scale for appetite min: 0; max: 10. The higher values indicate worse appetite
Karnofsky performance status	2018 - 2020	Karnofsky performance status
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
Numeric rating scale for pain	2018 - 2020	Numeric rating scale for pain min: 0; max: 10. The higher values indicate worse pain.
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

Trial Locations

Locations (2)

Peking University International Hospital; 🇨🇳 Beijing, Beijing, China

NanJing PLA 81 Hospital; 🇨🇳 Nanjing, Jiangsu, China