Status:
UNKNOWN
CH1701 for Prevention and Treatment of Radiation Burns
Lead Sponsor:
Vietlife Healthcare Corporation
Collaborating Sponsors:
Vietnam National Cancer Hospital
Conditions:
Cancer
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
A combined Phase I\&II, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for prevention and treatment of radiation therapy burn of CH1701
Eligibility Criteria
Inclusion
- \*Phase I:
- Healthy volunteers, aged 18 and older at the time of enrollment
- Voluntarily participate in the study by signing a consent form to participate in the study
- Ability to adhere to treatment according to researchers' assessment
Exclusion
- Subjects with other acute or chronic diseases need to be treated
- It is not possible to comply with the research or studied drug treatment process in the opinion of the researcher
- Phase II:
- Inclusion Criteria:
- Female patient, aged 18 to 60 years old
- Having been diagnosed with breast cancer with axillary lymph node metastasis, having radiation therapy for radiation therapy in the range of 45-50 Gy for a period of 5-6 weeks
- Treatment can be started within 3 days of signing the consent to participate in the study
- Agree to voluntarily sign the consent form to participate in the study
Key Trial Info
Start Date :
July 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04386343
Start Date
July 5 2019
End Date
December 1 2020
Last Update
August 24 2020
Active Locations (1)
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1
Vietlife Healthcare Corporation
Hanoi, Vietnam