A Multicenter Real World Study of Kanglaite for Cancer Cachexia

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 20, 2020

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Overall survival
    • Time Frame: 2018 – 2020
    • Overall survival

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhejiang Kanglaite Pharmaceutical Co.Ltd
  • Collaborator
    • NanJing PLA 81 Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shukui Qin, MD, Principal Investigator, NanJing PLA 81 Hospital
  • Overall Contact(s)
    • Shukui Qin, MD, 0086-025-84453932, qinsk@csco.org.cn

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