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
Overview
- Phase
- Phase 1
- Intervention
- Safety assessment of CH1701
- Conditions
- Cancer
- Sponsor
- Vietlife Healthcare Corporation
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Side effects by skin biopsy
- Last Updated
- 5 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Safety assessment of CH1701
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
Intervention: Safety assessment of CH1701
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
Intervention: Safety assessment of CH1701
Placebo arm - Phase II
20 Breast cancer patients will use Placebo in the radiation affected area right after radiation
Intervention: Placebos
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
Intervention: CH1701 for prevention and treatment of radiation burns.
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
Intervention: CH1701 for prevention and treatment of radiation burns.
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
Intervention: CH1701 for prevention and treatment of radiation burns.
Outcomes
Primary Outcomes
Side effects by skin biopsy
Time Frame: 14 days
Skin biopsy after 14 days of topical application, compared with healthy skin
Degree of burns according to CTCAE 4.03 atlas
Time Frame: 63 days
Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns