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

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

Study Overview

• Status: Unknown
• Conditions: Cancer Cachexia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102206
      • Peking University International Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Nanjing PLA 81 Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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%;

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events	2018 - 2020
Serious adverse event	Serious adverse event	2018 - 2020

Collaborators and Investigators

• Sponsor: Zhejiang Kanglaite Pharmaceutical Co.Ltd
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.; NanJing PLA 81 Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 20, 2018
• Primary Completion (Anticipated): March 20, 2020
• Study Completion (Anticipated): July 20, 2020

Study Registration Dates

• First Submitted: August 12, 2018
• First Submitted That Met QC Criteria: August 12, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Overall survival; Cancer cachexia; Kanglaita Injection/Capsule; Real-world evidences
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: KLT-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No