Cancer
Conditions
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
Interventions
DRUGCH1701 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.
DRUGSafety assessment of CH1701
Safety assessment of CH1701 after 14 days of use on volunteers
DRUGPlacebos
The placebo was used on patients as a control for the doses of CH1701
Sponsors
Vietnam National Cancer Hospital
Vietlife Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigator are blinded to the treatment
Intervention model description
Phase I: Three dose level - 50%, 100% and 167% of the expected dose level Phase II: Four dose level - 0% (Placebo), 50%, 100% and 167% of the expected dose level
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
\*Phase I: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Vietnam
Outcome results
None listed