CH1701 for Prevention and Treatment of Radiation Burns (CH1701)

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

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

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Drug: Safety assessment of CH1701; Drug: Placebos; Drug: CH1701 for prevention and treatment of radiation burns.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Vietlife Healthcare Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

*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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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	Drug: Safety assessment of CH1701; Safety assessment of CH1701 after 14 days of use on volunteers
PLACEBO_COMPARATOR: 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	Drug: Safety assessment of CH1701; Safety assessment of CH1701 after 14 days of use on volunteers
ACTIVE_COMPARATOR: 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	Drug: Safety assessment of CH1701; Safety assessment of CH1701 after 14 days of use on volunteers
PLACEBO_COMPARATOR: Placebo arm - Phase II; 20 Breast cancer patients will use Placebo in the radiation affected area right after radiation	Drug: Placebos; The placebo was used on patients as a control for the doses of CH1701
PLACEBO_COMPARATOR: 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	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.
PLACEBO_COMPARATOR: 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	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.
PLACEBO_COMPARATOR: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects by skin biopsy	Skin biopsy after 14 days of topical application, compared with healthy skin	14 days
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

Collaborators and Investigators

• Sponsor: Vietlife Healthcare Corporation
• Collaborators: Vietnam National Cancer Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: August 25, 2019
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (ACTUAL): May 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CH1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No