CH1701 for Prevention and Treatment of Radiation Burns (CH1701)

August 21, 2020 updated by: Vietlife Healthcare Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Vietlife Healthcare Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Side effects by skin biopsy
Time Frame: 14 days
Skin biopsy after 14 days of topical application, compared with healthy skin
14 days
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
63 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vietlife Healthcare Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vietnam National Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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