Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel

September 4, 2023 updated by: Ying-Chun Lin, China Medical University Hospital

A Single Center, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel

The radiotherapy after surgery reduces the risk of recurrence and death is widely used for standard treatment for cancer including breast cancer and head and neck cancer. However, radiation dermatitis is a common side effect and major adverse event of radiotherapy. Radiation induces skin inflammation resulting in redness, itchiness and peeling skin. Radiation dermatitis may be acute or chronic. Acute skin changes occur within 90 days of initiating therapy due to inflammation and DNA damage and chronic skin changes may occur after several weeks or years. Radiation-irritated skin is a treatment-induced symptom caused by radiation dose-limiting toxicity. It damages skin structure and causes a variety of symptoms of cuticle thinning, reducing of collagen in subcutaneous, sweat glands damage, sebaceous glands damage and basal membrane damage. These conditions lead patients to lost work productivity, wound care costs, social isolation, altered body image and affect a patient's quality of life and mental health both during and after treatment and even interrupts the treatment schedule.

The treatment of radiation dermatitis is an essential component of radiotherapy. The common treatment includes agents and other dressing products, such as corticosteroid cream, hyaluronic acid, aloe and sucralfate, which are used to prevent or reduce severity of dermatitis. But there is no clear therapeutic or nursing guideline supporting continuous treatment of radiation dermatitis by topical agents currently.

In this study, Radiation Care® gel which contain Japanese honeysuckle extract will be used in breast and head and neck cancer patients to test the safety and efficacy to prevent radiation dermatitis and alleviate their radiation-irritated skin symptoms.

The primary objective of this study is to evaluate the clinical outcomes of "Radiation Care" gel application in breast cancer and head and neck cancer patients who have radiation dermatitis or radiation-irritated skin due to the radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

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

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must be males or non-pregnant or non-lactating females at least 20 years of age.

  • Subject must meet one of the following conditions:

    1. Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.
    2. Diagnosis of epithelial carcinoma of nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, paranasal sinus and salivary glands which were treated with or without operation, concurrent chemotherapy is accepted, in head and neck cancer patients.
  • Patients were scheduled to receive at least three sessions of radiotherapy per week (1 session per day) for at least five weeks using standard irradiation fraction (with at least 1.8 Gy per session) for total dose of at least 50 Gy.
  • Participant willing and must give signed informed consent.

Exclusion Criteria:

  • Prior breast reconstructions, implants, and/or expanders.
  • Previous radiotherapy to the area to be treated with radiation therapy (head and neck area or breast and thorax areas).
  • Concurrent chemotherapy in breast cancer patients.
  • Concurrent targeted therapy in head and neck cancer patients.
  • Known radiosensitivity syndromes (e.g. Ataxia-telangiectasia)
  • Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections, rashes or unhealed wounds in the radiation field or systemic lupus erythematosus (SLE).
  • Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure.
  • Use of a tissue-equivalent bolus.
  • Use of over-the-counter topical medications containing steroids.
  • 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: Radiation Care Gel application
Radiation Care® gel is instructed to use on the target skin area accepted radiation therapy twice daily.
Other: Radiation Care Gel
The investigational medical product of this study is a hydrogel, Radiation Care® gel which increases moisturizing and it can be applied to the target areas including skin folds and creases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To observe the proportion of patients with grade 2 radiation dermatitis (according to CTCAE) at week 5.
Time Frame: at 5 weeks

According to Common Terminology Criteria for Adverse Events (CTCAE) system by national cancer institute, radiation induced skin toxicities is scored in severity in the following grades:

Grade 1: faint erythema or dry desquamation Grade 2: moderate to brisk erythema; moist desquamation confined to skin folds; moderate edema Grade 3: moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: skin necrosis or large ulcerations; spontaneous bleeding or require surgical procedures Grade 5: with lethal consequences
at 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate radiation-irritated situation after 3 months of Radiation Care® gel application in breast cancer and head and neck cancer patients who completed the post-operative radiotherapy.
Time Frame: Day0 (baseline), 1-Week, 2-Week, 3-Week, 4-Week, 5-Week, 6-Week, 7-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week

The skin condition of target area will be observed and recorded at clinical visit. The measurement include:

  1. Erythema grade:

    Grade 1: Very faint erythema: Skin has a very light pink color. Grade 2: Faint erythema: Skin reaction is more apparent with clear borders but is still pink with more intensity.

    Grade 3: Bright erythema: Erythema is apparent in bright pink and borders are clearly defined.

    Grade 4: Very bright erythema: Skin is bright red, borders are very well defined, capillaries and bruising may be visible.

  2. Graded according to CTCAE rate
  3. Moisture percentage will be detected by MoistureMeter SC
Day0 (baseline), 1-Week, 2-Week, 3-Week, 4-Week, 5-Week, 6-Week, 7-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week
To compare the moisture percentage at the radiotherapy site from baseline to follow-up visit.
Time Frame: Up to 12-13 weeks (depend on different times of radiotherapy in breast cancer and head and neck cancer): From Day0 (baseline) to 2-Week, 4-Week, 6-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week (End of study)
Moisture percentage will be detected by MoistureMeter SC for every two weeks.
Up to 12-13 weeks (depend on different times of radiotherapy in breast cancer and head and neck cancer): From Day0 (baseline) to 2-Week, 4-Week, 6-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week (End of study)
The score of quality of life with the Skindex-16 questionnaire performed every two weeks.
Time Frame: Up to 12-13 weeks (depend on different times of radiotherapy in breast cancer and head and neck cancer): From Day0 (baseline) to 2-Week, 4-Week, 6-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week (End of study)
The Skindex-16 is an assessment using numerical analog scales (0 = never bothered to 6 = always bothered), used to comprehensively measure the effects of skin diseases on subject's quality of life including burden of symptoms, social function and emotional state that the CTCAE does not take into account. The higher scores present poorer quality of life.
Up to 12-13 weeks (depend on different times of radiotherapy in breast cancer and head and neck cancer): From Day0 (baseline) to 2-Week, 4-Week, 6-Week, Post-radiotherapy 2-week, Post-radiotherapy 6-week (End of study)

Collaborators and Investigators

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

Sponsor

China Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 3, 2021

Primary Completion (Actual)

August 26, 2022

Study Completion (Actual)

October 7, 2022

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH110-REC1-122

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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