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Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing

Primary Purpose

Breast Cancer, Radiation Dermatitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FR-101 Chest Dressing
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring radiation-irritated skin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must be males or non-pregnant females at least 20 years of age. Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment. Patients were scheduled to receive five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy or hypofraction irradiation fraction(with 2.66 Gy per session) for total dose of at least 42.56 Gy. Participant must give informed consent. Exclusion Criteria: Bilateral breast cancer Previous radiotherapy to the chest Chemotherapy concurrent with radiation treatment Prior breast reconstructions, implants, and/or expanders Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia) Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE) Participation in any clinical trial in the prior 30 days from baseline. Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    FR-101 Dressing use

    Arm Description

    Subject will use FR-101 chest dressing on the target skin area accepted radiation therapy once every 2 days.

    Outcomes

    Primary Outcome Measures

    Worst skin toxicity during treatment and until 2 weeks after according to CTCAE grading.
    Skin toxicity at the radiotherapy site will be assessed by investigator and NCI CTCAE v5.0 will be used for grading, on a scale of: Grade 1 (faint erythema or dry desquamation); Grade 2 (moderate to brisk erythema;patchy moist desquamation,mostly confined to skin foldsand creases; moderate edema); Grade 3 (moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion); Grade 4 (life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated); Grade 5 (death)

    Secondary Outcome Measures

    To compare the skin moisture percentage.
    To compare the skin moisture percentage at the radiotherapy site and normal site from baseline to follow-up visit.
    To compare the skin trans-epidermal water loss.
    To compare the skin trans-epidermal water loss at the radiotherapy site and normal site from baseline to follow-up visit.
    To compare the skin temperature of target region.
    To compare the skin temperature of target region at the radiotherapy site and normal site from baseline to follow-up visit.
    The score of quality of life with the Skindex-16 questionnaire.
    The score of quality of life will be assessed using the Skindex-16 questionnaire every two weeks. Participants answer 16 questions on a scale from 0 (not at all) to 6 (always). The quality of life is calculated by summing the scores for all questions, resulting in a maximum of 96 and a minimum of 0; higher scores indicate a more impaired quality of life.
    Median time to G2 radiation dermatitis development
    Median time to G2 radiation dermatitis development according to CTCAE.

    Full Information

    First Posted
    September 1, 2023
    Last Updated
    September 15, 2023
    Sponsor
    China Medical University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06040983
    Brief Title
    Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
    Official Title
    Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 18, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Medical University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Breast cancer is the top one incidence of cancer in women. Whole breast radiation therapy plays an indispensable role in the course of breast cancer treatment, and the radiation dermatitis is the major side effect affected quality of life. Radiation dermatitis can be divided into acute and chronic. Severe acute radiation dermatitis affects the quality of life of patients during the course of treatment, and may cause treatment interruption and affect the efficacy. Chronic radiation dermatitis may cause irreversible skin problems, and lead to so-called "radiation-irritated skin" (radiation-irritated skin) seriously affects the quality of life of breast cancer patients after treatment. This study will enroll 30 breast cancer patients who received whole breast radiation therapy after breast conserving surgery. Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days, taking care of avoiding applications from 1 to 4 h before treatment to prevent "Build-up" effect. Subjects will need to come back to clinics for assessment weekly during radiotherapy, 2 weeks after radiotherapy, and 6 weeks after radiotherapy. The evaluation includes physical examinations, questionnaire surveys, skin observation and measurements, and photographs. The total study time is at least 3 months. The target area of radiation-irritated skin condition will be observed and graded according to CTCAE rate. The skin physiological parameters will be detected by MoistureMeter SC, Vapometer, SkinColorCatch and HX-YL001 infrared thermometer. Statistical analysis of skin physiological parameters is used to evaluate the efficacy of FR-101 chest dressing on the prevention of acute radiation dermatitis after radiotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Radiation Dermatitis
    Keywords
    radiation-irritated skin

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FR-101 Dressing use
    Arm Type
    Experimental
    Arm Description
    Subject will use FR-101 chest dressing on the target skin area accepted radiation therapy once every 2 days.
    Intervention Type
    Device
    Intervention Name(s)
    FR-101 Chest Dressing
    Intervention Description
    Subject will receive FR-101 chest dressing and be instructed to use the product on the target skin area accepted radiation therapy once every 2 days, taking care of avoiding applications from 1 to 4 h before treatment to prevent "Build-up" effect. If the application time is longer than the recommendation, discomfort may happen depending on subject's condition.
    Primary Outcome Measure Information:
    Title
    Worst skin toxicity during treatment and until 2 weeks after according to CTCAE grading.
    Description
    Skin toxicity at the radiotherapy site will be assessed by investigator and NCI CTCAE v5.0 will be used for grading, on a scale of: Grade 1 (faint erythema or dry desquamation); Grade 2 (moderate to brisk erythema;patchy moist desquamation,mostly confined to skin foldsand creases; moderate edema); Grade 3 (moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion); Grade 4 (life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated); Grade 5 (death)
    Time Frame
    1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later
    Secondary Outcome Measure Information:
    Title
    To compare the skin moisture percentage.
    Description
    To compare the skin moisture percentage at the radiotherapy site and normal site from baseline to follow-up visit.
    Time Frame
    1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
    Title
    To compare the skin trans-epidermal water loss.
    Description
    To compare the skin trans-epidermal water loss at the radiotherapy site and normal site from baseline to follow-up visit.
    Time Frame
    1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
    Title
    To compare the skin temperature of target region.
    Description
    To compare the skin temperature of target region at the radiotherapy site and normal site from baseline to follow-up visit.
    Time Frame
    1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
    Title
    The score of quality of life with the Skindex-16 questionnaire.
    Description
    The score of quality of life will be assessed using the Skindex-16 questionnaire every two weeks. Participants answer 16 questions on a scale from 0 (not at all) to 6 (always). The quality of life is calculated by summing the scores for all questions, resulting in a maximum of 96 and a minimum of 0; higher scores indicate a more impaired quality of life.
    Time Frame
    1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
    Title
    Median time to G2 radiation dermatitis development
    Description
    Median time to G2 radiation dermatitis development according to CTCAE.
    Time Frame
    1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must be males or non-pregnant females at least 20 years of age. Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment. Patients were scheduled to receive five sessions of radiotherapy per week (1 session per day) for at least four weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 45 Gy or hypofraction irradiation fraction(with 2.66 Gy per session) for total dose of at least 42.56 Gy. Participant must give informed consent. Exclusion Criteria: Bilateral breast cancer Previous radiotherapy to the chest Chemotherapy concurrent with radiation treatment Prior breast reconstructions, implants, and/or expanders Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia) Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections or systemic lupus erythematosus (SLE) Participation in any clinical trial in the prior 30 days from baseline. Any condition that, in the judgement of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing

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