A Multicenter Real World Study of Kanglaite for Cancer Cachexia

NCT ID: NCT03631459

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-20

Study Completion Date

2020-07-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer Cachexia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Kanglaite Injection/Capsules

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Coicis oil injection, Z10970091 Coix seed oil triglyceride, 03004812Z

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NanJing PLA 81 Hospital

OTHER

Sponsor Role collaborator

LinkDoc Technology (Beijing) Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Zhejiang Kanglaite Pharmaceutical Co.Ltd

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shukui Qin, MD

Role: PRINCIPAL_INVESTIGATOR

NanJing PLA 81 Hospital

Locations

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Peking University International Hospital

Beijing, Beijing Municipality, China

Site Status

NanJing PLA 81 Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Shukui Qin, MD

Role: CONTACT

0086-025-84453932

Facility Contacts

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Jun Liang, MD

Role: primary

+86-010-69006900

Shukui Qin, MD

Role: primary

+86-025-84453932

Other Identifiers

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KLT-2018

Identifier Type: -

Identifier Source: org_study_id

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