Breast CancerNCT06040983
Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
A study testing FR-101 Chest Dressing in people with Breast Cancer and Radiation Dermatitis, run by China Medical University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis
- What is being tested?
- FR-101 Chest Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
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.
Read more
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.
- Conditions
- Breast Cancer, Radiation Dermatitis
- Being tested
- FR-101 Chest Dressing
- Keywords
- radiation-irritated skin
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FR-101 Chest DressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FR-101 Dressing use | Experimental | Subject will use FR-101 chest dressing on the target skin area accepted radiation therapy once every 2 days. Receives: Device: FR-101 Chest Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1-Week (Day0), 2-Week (Day7), 3-Week (Day14), 4-Week (Day21), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later
Secondary outcomes (5)
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.
Measured: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
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.
Measured: 1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
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.
Measured: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
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.
Measured: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
Median time to G2 radiation dermatitis development
Median time to G2 radiation dermatitis development according to CTCAE.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start18 Sep 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Ying Liao, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040983
- Sponsor's protocol ID
- CMUH112-REC1-001
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With FR-101 Chest Dressing
- ClinicalTrials.gov ID
- NCT06040983
- Acronym / sponsor ID
- CMUH112-REC1-001
- Conditions
- Breast Cancer, Radiation Dermatitis
- Keywords
- radiation-irritated skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FR-101 Dressing use | Experimental | Device: FR-101 Chest DressingSubject will use FR-101 chest dressing on the target skin area accepted radiation therapy once every 2 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FR-101 Chest DressingSubject 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. | Device | FR-101 Dressing use |
Primary outcome
Worst skin toxicity during treatment and until 2 weeks after according to CTCAE grading.
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
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)
5 secondary outcomes
To compare the skin moisture percentage.
Time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
To compare the skin trans-epidermal water loss.
Time frame: 1-Week (Day0), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
To compare the skin temperature of target region.
Time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
The score of quality of life with the Skindex-16 questionnaire.
Time frame: 1-Week (Day0), 3-Week (Day14), 5-Week (Day28), 6-Week (Day35), Post-radiotherapy 2 Week later, Post-radiotherapy 6 Week later
Median time to G2 radiation dermatitis development
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FR-101 Chest Dressing in people with Breast Cancer and Radiation Dermatitis, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst skin toxicity during treatment and until 2 weeks after according to CTCAE grading. (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.