Radiation DermatitisNCT04995328
Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel
A study testing Radiation Care Gel in people with Radiation Dermatitis, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Radiation Care Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2021to 7 Oct 2022
- 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 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Radiation Dermatitis
- Being tested
- Radiation Care Gel
- Keywords
- Lonicera japonica, breast cancer, head and neck cancer
- Medical subject headings
- Radiodermatitis, Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Care GelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Care Gel application | Experimental | Radiation Care® gel is instructed to use on the target skin area accepted radiation therapy twice daily. Receives: Other: Radiation Care Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 5 weeks
Secondary outcomes (3)
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
Measured: 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.
Moisture percentage will be detected by MoistureMeter SC for every two weeks.
Measured: 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.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start3 Aug 2021
- Primary completion26 Aug 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Radiation DermatitisStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying-Chun Lin, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995328
- Sponsor's protocol ID
- CMUH110-REC1-122
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31882508Clemenson 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.
PubMed 31063799Wang 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.
PubMed 27403439Jeong 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.
PubMed 26051519Wu 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.
PubMed 17726749Liao 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.
PubMed 23392856
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Radiation Care® Gel
- ClinicalTrials.gov ID
- NCT04995328
- Acronym / sponsor ID
- CMUH110-REC1-122
- Conditions
- Radiation Dermatitis
- Keywords
- Lonicera japonica, breast cancer, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 6 Aug 2021 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Care Gel application | Experimental | Other: Radiation Care GelRadiation Care® gel is instructed to use on the target skin area accepted radiation therapy twice daily. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (11 listed)
- 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)
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 |
|---|---|---|
| Radiation Care GelThe 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. | Other | Radiation Care Gel application |
Primary outcome
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
3 secondary outcomes
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
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 31882508Ahn 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.
- Background: PubMed 31063799Clemenson 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.
- Background: PubMed 27403439Wang 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.
- Background: PubMed 26051519Jeong 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.
- Background: PubMed 17726749Wu 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.
- Background: PubMed 23392856Liao 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Care Gel in people with Radiation Dermatitis, run by China Medical University Hospital at 1 site in Taiwan.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To observe the proportion of patients with grade 2 radiation dermatitis (according to CTCAE) at week 5. (time frame: at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04995328, which also lists 6 linked publications.
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 6 Sep 2023.