Abstract
Background: Radiation-induced dermatitis (RID) is a common complication of radiation therapy (RT). Although it has a high prevalence and can even trigger the premature end of conventional cancer therapies, there is no standard management. This study aims to evaluate whether topical use of Jaungo (Shiunko), a traditional herbal ointment mainly composed of Lithospermi radix and Angelica sinensis, could reduce RID compared to the water-in-oil type non-steroidal moisturizer in patients with breast cancer.Methods: This is a prospective, single-blinded, randomized controlled pilot trial that investigates the effect of topical application of Jaungo for the prevention of RID in postoperative breast cancer patients scheduled for RT, in comparison with the non-steroidal moisturizer, with a random distribution of 50 patients across the two groups. RT will be administered for 5–7 weeks with a biological equivalent dose (BED10) of 60 Gy or more, and the interventions will be applied 3 times a day during RT duration. Participants will be assessed a total of nine times, including eight visits during the period of RT and one visit at a 2-week follow-up period after the end of treatment. The incidence and severity of RID, quality of life, skin reaction symptoms, and maximum pain related to RID will be measured. The incidence rate of grade 2 or higher RID using the Radiation Therapy Oncology Group (RTOG) in the two groups will be statistically compared as the primary outcome. The types and frequencies of adverse events will be also collected and evaluated. All assessments will be performed by independent radiology oncologists.Discussion: This trial is currently ongoing and is recruiting. This study will determine the preventive efficacy of Jaungo in RID with postoperative breast cancer patients and provide evidence in traditional Korean medicine clinical practice.
Highlights
Radiation-induced dermatitis (RID) is one of the most common complications of radiation therapy (RT) in patients with breast cancer (Bolderston et al, 2006), and it presents with a variety of symptoms such as pruritus, erythema, edema, desquamation, necrosis, ulceration, and hemorrhage
1) The subjects or their families withdraw consent to participate in the trial; 2) a violation of the inclusion/exclusion criteria is found during the trial; 3) a significant adverse event appears in the subject and/or it is difficult to continue the trial due to an adverse reaction; 4) any violation of the study protocol; 5) the compliance level of the intervention (Jaungo or moisturizer) is less than 70%; 6) subjects who take medications, etc. that may affect the results of this study without confirmation from the attending physician; 7) any cases that the attending physician judge as inappropriate to the trial; 8) subjects who pregnant during the trial period; 9)
The symptoms and frequencies of adverse reactions related to the intervention medication will be analyzed separately. This is a prospective, single-blinded, pilot randomized-controlled trial to compare the preventive efficacy of Jaungo ointment and the water-in-oil type non-steroidal moisturizer for RID in patients with breast cancer undergoing RT after surgery
Summary
Radiation-induced dermatitis (RID) is one of the most common complications of radiation therapy (RT) in patients with breast cancer (Bolderston et al, 2006), and it presents with a variety of symptoms such as pruritus, erythema, edema, desquamation, necrosis, ulceration, and hemorrhage. Several interventions for preventing or reducing RID, including systemic oral medications, skin care practices, steroidal topical therapies, non-steroidal therapies, and dressings have been evaluated, there is no standard treatment that has clearly demonstrated its effectiveness (Chan et al, 2014). A water-in-oil type non-steroidal moisturizer containing hyaluronic acid as the main component has shown potential as effective in preventing and minimizing RID in patients with breast cancer compared to an emollient base cream regarding the maximum severity of skin toxicity, burning, and desquamation (Primavera et al, 2006). Radiation-induced dermatitis (RID) is a common complication of radiation therapy (RT) It has a high prevalence and can even trigger the premature end of conventional cancer therapies, there is no standard management. This study aims to evaluate whether topical use of Jaungo (Shiunko), a traditional herbal ointment mainly composed of Lithospermi radix and Angelica sinensis, could reduce RID compared to the water-in-oil type non-steroidal moisturizer in patients with breast cancer
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