A Multicenter Real World Study of Kanglaite for Cancer Cachexia

Zhejiang Kanglaite Pharmaceutical Co.Ltd100,000 enrolled

Overview

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

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

100,000

Conditions

Cancer Cachexia

Interventions

Kanglaite Injection/CapsulesDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (2)

Peking University International Hospital

Beijing, Beijing Municipality, China

NanJing PLA 81 Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Overall survival

Time frame: 2018 - 2020

Secondary Outcomes

Lean body mass

Time frame: 2018 - 2020

Body weight

Time frame: 2018 - 2020

Grade of cachexia

Time frame: 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

Time frame: 2018 - 2020

Karnofsky performance status

Time frame: 2018 - 2020

Patient-generated subjective global assessment (PG-SGA)

Time frame: 2018 - 2020

Numeric rating scale for pain

Numeric rating scale for pain min: 0; max: 10. The higher values indicate worse pain.

Time frame: 2018 - 2020

Numeric rating scale for appetite

Central Contacts

Shukui Qin, MD

CONTACT

0086-025-84453932 qinsk@csco.org.cn

Data from ClinicalTrials.gov

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