Study Results
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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UNKNOWN
PHASE1/PHASE2
92 participants
INTERVENTIONAL
2019-07-05
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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50% dose level arm - Phase I
4 healthy volunteer will use 50% dose level for Phase I in the left hand side and use placebo in the right hand side
Safety assessment of CH1701
Safety assessment of CH1701 after 14 days of use on volunteers
100% dose level arm - Phase I
4 healthy volunteer will use 100% dose level for Phase I in the left hand side and use placebo in the right hand side
Safety assessment of CH1701
Safety assessment of CH1701 after 14 days of use on volunteers
167% dose level arm - Phase I
4 healthy volunteer will use 167% dose level for Phase I in the left hand side and use placebo in the right hand side
Safety assessment of CH1701
Safety assessment of CH1701 after 14 days of use on volunteers
Placebo arm - Phase II
20 Breast cancer patients will use Placebo in the radiation affected area right after radiation
Placebos
The placebo was used on patients as a control for the doses of CH1701
50% dose level arm - Phase II
20 Breast cancer patients will use CH1701 with 50% of the expected dose level in the radiation affected area right after radiation
CH1701 for prevention and treatment of radiation burns.
Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.
100% dose level arm - Phase II
20 Breast cancer patients will use CH1701 with 100% of the expected dose level in the radiation affected area right after radiation
CH1701 for prevention and treatment of radiation burns.
Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.
167% dose level arm - Phase II
20 Breast cancer patients will use CH1701 with 167% of the expected dose level in the radiation affected area right after radiation
CH1701 for prevention and treatment of radiation burns.
Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.
Interventions
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CH1701 for prevention and treatment of radiation burns.
Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.
Safety assessment of CH1701
Safety assessment of CH1701 after 14 days of use on volunteers
Placebos
The placebo was used on patients as a control for the doses of CH1701
Eligibility Criteria
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Inclusion Criteria
* Voluntarily participate in the study by signing a consent form to participate in the study
* Ability to adhere to treatment according to researchers' assessment
* 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
Exclusion Criteria
* It is not possible to comply with the research or studied drug treatment process in the opinion of the researcher
* Phase II:
* The available skin lesions in the breast and chest and according to the researchers' judgment will affect the assessment of inflammation caused by radiation
* The patient had radiation therapy before the breast area
* History of connective tissue disorders
* The patient is incapable of complying with the research procedures or is unable to ensure compliance with the study medication as assessed by the researcher
* Participate in other clinical trial studies within 1 month before joining this study
18 Years
60 Years
ALL
Yes
Sponsors
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Vietnam National Cancer Hospital
INDIV
Vietlife Healthcare Corporation
OTHER_GOV
Responsible Party
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Locations
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Vietlife Healthcare Corporation
Hanoi, , Vietnam
Countries
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Other Identifiers
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CH1701
Identifier Type: -
Identifier Source: org_study_id
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