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

September 15, 2023 updated by: Chih-Ying Liao, China Medical University Hospital

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FR-101 Dressing use
Subject will use FR-101 chest dressing on the target skin area accepted radiation therapy once every 2 days.
Device: FR-101 Chest Dressing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Measures

Outcome Measure
Measure Description
Time Frame
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 moisture percentage at the radiotherapy site and normal site from baseline to follow-up visit.
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 trans-epidermal water loss at the radiotherapy site and normal site from baseline to follow-up visit.
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
To compare the skin temperature of target region at the radiotherapy site and normal site from baseline to follow-up visit.
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
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.
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
Median time to G2 radiation dermatitis development according to CTCAE.
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

Collaborators and Investigators

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

Sponsor

China Medical University 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 (Estimated)

September 18, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC1-001

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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