CH1701 for Prevention and Treatment of Radiation Burns
Phase 1
- Conditions
- Cancer
- Interventions
- Drug: Safety assessment of CH1701Drug: CH1701 for prevention and treatment of radiation burns.Drug: Placebos
- Registration Number
- NCT04386343
- Lead Sponsor
- Vietlife Healthcare Corporation
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
- 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 Criteria
-
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
Exclusion Criteria:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100% dose level arm - Phase I Safety assessment of CH1701 4 healthy volunteer will use 100% dose level for Phase I in the left hand side and use placebo in the right hand side 167% dose level arm - Phase I Safety assessment of CH1701 4 healthy volunteer will use 167% dose level for Phase I in the left hand side and use placebo in the right hand side 50% dose level arm - Phase I Safety assessment of CH1701 4 healthy volunteer will use 50% dose level for Phase I in the left hand side and use placebo in the right hand side 50% dose level arm - Phase II CH1701 for prevention and treatment of radiation burns. 20 Breast cancer patients will use CH1701 with 50% of the expected dose level in the radiation affected area right after radiation 100% dose level arm - Phase II CH1701 for prevention and treatment of radiation burns. 20 Breast cancer patients will use CH1701 with 100% of the expected dose level in the radiation affected area right after radiation Placebo arm - Phase II Placebos 20 Breast cancer patients will use Placebo in the radiation affected area right after radiation 167% dose level arm - Phase II CH1701 for prevention and treatment of radiation burns. 20 Breast cancer patients will use CH1701 with 167% of the expected dose level in the radiation affected area right after radiation
- Primary Outcome Measures
Name Time Method Side effects by skin biopsy 14 days Skin biopsy after 14 days of topical application, compared with healthy skin
Degree of burns according to CTCAE 4.03 atlas 63 days Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vietlife Healthcare Corporation
🇻🇳Hanoi, Vietnam