A Multicenter Real World Study of Kanglaite for Cancer Cachexia

Cancer Cachexia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03631459
• Other study ID #: KLT-2018
• Status: Not yet recruiting
• Start date: August 20, 2018
• Est. completion date: July 20, 2020

Study information

• Verified date: August 2018
• Source: Zhejiang Kanglaite Pharmaceutical Co.Ltd
• Contact: Shukui Qin, MD
• Phone: 0086-025-84453932
• Email: qinsk[@]csco.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100000
• Est. completion date: July 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

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

Locations

Country	Name	City	State
China	Peking University International Hospital	Beijing	Beijing
China	NanJing PLA 81 Hospital	Nanjing	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Zhejiang Kanglaite Pharmaceutical Co.Ltd	LinkDoc Technology (Beijing) Co. Ltd., NanJing PLA 81 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events	2018 - 2020
Other	Serious adverse event	Serious adverse event	2018 - 2020
Primary	Overall survival	Overall survival	2018 - 2020
Secondary	Lean body mass	Lean body mass	2018 - 2020
Secondary	Body weight	Body weight	2018 - 2020
Secondary	Grade of cachexia	Grade of cachexia	2018 - 2020
Secondary	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
Secondary	Karnofsky performance status	Karnofsky performance status	2018 - 2020
Secondary	Patient-generated subjective global assessment (PG-SGA)	Patient-generated subjective global assessment (PG-SGA)	2018 - 2020
Secondary	Numeric rating scale for pain	Numeric rating scale for pain min: 0; max: 10. The higher values indicate worse pain.	2018 - 2020
Secondary	Numeric rating scale for appetite	Numeric rating scale for appetite min: 0; max: 10. The higher values indicate worse appetite	2018 - 2020
Secondary	Synergistic antitumor effect: Overall response rate	Synergistic antitumor effect: Overall response rate	2018 - 2020
Secondary	Synergistic antitumor effect: Disease control rate	Synergistic antitumor effect: Disease control rate	2018 - 2020