An interventional study of Radiation Care Gel in Radiation Dermatitis, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Supportive care
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.
1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.
This study's enrollment of 23 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject must meet one of the following conditions:
Exclusion Criteria:
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.
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
Time frame: at 5 weeks
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: 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
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.
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)
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.
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)
Plan to share: Undecided
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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China Medical University Hospital