CH1701 for Prevention and Treatment of Radiation Burns (NCT04386343) | Clinical Trial Compass
UnknownPhase 1/2
CH1701 for Prevention and Treatment of Radiation Burns
Vietnam92 participantsStarted 2019-07-05
Plain-language 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
Who can participate
Age range18 Years ā 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
\*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
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