Back to resultsClinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Radiation Care Gel
Sponsored by
About this trial
This is an interventional supportive care trial for Radiation Dermatitis focused on measuring Lonicera japonica, breast cancer, head and neck cancer
Eligibility Criteria
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:
- Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.
- 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.
Sites / Locations
- China Medical University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation Care Gel application
Arm Description
Radiation Care® gel is instructed to use on the target skin area accepted radiation therapy twice daily.
Outcomes
Primary Outcome Measures
To observe the proportion of patients with grade 2 radiation dermatitis (according to CTCAE) at week 5.
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
Secondary Outcome Measures
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.
The skin condition of target area will be observed and recorded at clinical visit. The measurement include:
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.
Graded according to CTCAE rate
Moisture percentage will be detected by MoistureMeter SC
To compare the moisture percentage at the radiotherapy site from baseline to follow-up visit.
Moisture percentage will be detected by MoistureMeter SC for every two weeks.
The score of quality of life with the Skindex-16 questionnaire performed every two weeks.
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.
Full Information
NCT ID
NCT04995328
First Posted
July 21, 2021
Last Updated
September 4, 2023
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04995328
Brief Title
Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel
Official Title
A Single Center, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
August 26, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
Keywords
Lonicera japonica, breast cancer, head and neck cancer
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
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation Care Gel application
Arm Type
Experimental
Arm Description
Radiation Care® gel is instructed to use on the target skin area accepted radiation therapy twice daily.
Intervention Type
Other
Intervention Name(s)
Radiation Care Gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
To observe the proportion of patients with grade 2 radiation dermatitis (according to CTCAE) at week 5.
Description
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
Time Frame
at 5 weeks
Secondary Outcome Measure Information:
Title
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.
Description
The skin condition of target area will be observed and recorded at clinical visit. The measurement include:
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.
Graded according to CTCAE rate
Moisture percentage will be detected by MoistureMeter SC
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
Title
To compare the moisture percentage at the radiotherapy site from baseline to follow-up visit.
Description
Moisture percentage will be detected by MoistureMeter SC for 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)
Title
The score of quality of life with the Skindex-16 questionnaire performed every two weeks.
Description
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.
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)
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 or non-lactating females at least 20 years of age.
Subject must meet one of the following conditions:
Diagnosis of non-inflammatory breast adenocarcinoma or in situ breast cancer which were treated by operation with or without adjuvant or neoadjuvant hormonal treatment.
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.
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31882508
Citation
Ahn S, Sung K, Kim HJ, Choi YE, Lee YK, Kim JS, Lee SK, Roh JY. Reducing Radiation Dermatitis Using a Film-forming Silicone Gel During Breast Radiotherapy: A Pilot Randomized-controlled Trial. In Vivo. 2020 Jan-Feb;34(1):413-422. doi: 10.21873/invivo.11790.
Results Reference
background
PubMed Identifier
31063799
Citation
Clemenson C, Liu W, Bricout D, Soyez-Herkert L, Chargari C, Mondini M, Haddad R, Wang-Zhang X, Benel L, Bloy C, Deutsch E. Preventing Radiation-Induced Injury by Topical Application of an Amifostine Metabolite-Loaded Thermogel. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1141-1152. doi: 10.1016/j.ijrobp.2019.04.031. Epub 2019 May 4.
Results Reference
background
PubMed Identifier
27403439
Citation
Wang L, Jiang Q, Hu J, Zhang Y, Li J. Research Progress on Chemical Constituents of Lonicerae japonicae flos. Biomed Res Int. 2016;2016:8968940. doi: 10.1155/2016/8968940. Epub 2016 Jun 14.
Results Reference
background
PubMed Identifier
26051519
Citation
Jeong YT, Jeong SC, Hwang JS, Kim JH. Modulation effects of sweroside isolated from the Lonicera japonica on melanin synthesis. Chem Biol Interact. 2015 Aug 5;238:33-9. doi: 10.1016/j.cbi.2015.05.022. Epub 2015 Jun 5.
Results Reference
background
PubMed Identifier
17726749
Citation
Wu L. Effect of chlorogenic acid on antioxidant activity of Flos Lonicerae extracts. J Zhejiang Univ Sci B. 2007 Sep;8(9):673-9. doi: 10.1631/jzus.2007.B0673.
Results Reference
background
PubMed Identifier
23392856
Citation
Liao Y, Dong S, Kiyama R, Cai P, Liu L, Shen H. Flos lonicerae extracts and chlorogenic acid protect human umbilical vein endothelial cells from the toxic damage of perfluorooctane sulphonate. Inflammation. 2013 Jun;36(3):767-79. doi: 10.1007/s10753-013-9603-5.
Results Reference
background
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Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel
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