CH1701 for Prevention and Treatment of Radiation Burns

Cancer Clinical Trial

— CH1701  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04386343
• Other study ID #: CH1701
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 5, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2020
• Source: Vietlife Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: December 1, 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

*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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Vietnam	Vietlife Healthcare Corporation	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Vietlife Healthcare Corporation	Vietnam National Cancer Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects by skin biopsy	Skin biopsy after 14 days of topical application, compared with healthy skin	14 days
Primary	Degree of burns according to CTCAE 4.03 atlas	Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns	63 days