Radiation-Induced Skin Reaction Assessment Scale Research Articles

Clinical Effect of Moisturized Skin Care on Radiation Dermatitis of Head and Neck Cancer.

Radiation therapy (RT) for head and neck cancer may cause severe radiation dermatitis (RD) resulting in RT interruption and affecting disease control. A few studies address skin moisture changes during RT for head and neck cancer. The purpose of this study was to explore the effect of moisturized skin care (MSC) on severity of RD. The study includes newly diagnosed head and neck cancer patients undergoing RT. Participants were divided into MSC group and routine skin care (RSC) group based on patient's preferred decision. Skin moisture in the four quadrants of the neck was measured weekly before and after RT. RD was assessed with the Radiation Induced Skin Reaction Assessment Scale (RISRAS) and the Radiation Therapy Oncology Group (RTOG) acute skin toxicity grading criteria. A total of 54 patients were enrolled, of which 49 patients were suitable for the statistical analysis. There was a statistically significant difference in the RISRAS total score since the 5th week after RT between the groups. The severity of RD was less (B=0.814, p=0.021) and the onset was later (B=-0.384, p=0.006) in the MSC group when compared to the RSC group. Skin moisture decreased with cumulative radiation dose. In the upper neck, the MSC group had a slower rate of skin moisture decrease compared to the RSC group (right upper neck: B=0.935, p=0.007; left upper neck: B=0.93, p=0.018). MSC can effectively reduce the severity and delay the onset of RD, while slows down skin moisture decrease during RT.

Mepitel Film for the prevention of acute radiation dermatitis in breast cancer: A randomized multi-centre open-label phase 3 trial

390226 Background: Radiation dermatitis (RD) is common in patients undergoing breast radiation treatment (RT), with worse RD in patients with large breasts and after mastectomy. Mepitel Film (MF), a silicone-based polyurethane film with Safetac technology, may reduce RD. We hypothesized that MF might play a role in preventing RD in this group of patients at risk. Methods: Patients were randomly assigned to receive MF or standard skin care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type (lumpectomy vs. mastectomy), dose fractionation (conventional vs. hypofractionated), and administration of boost/bolus. The primary endpoint was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 during RT and within 3 months of completion of RT. Secondary endpoints included CTCAE G3, incidence of moist desquamation, use of topical antibiotic cream, and patient- (PROs) and clinician- (CRO) reported outcomes using the modified Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and Skin Symptom Assessment (SSA). This study is registered with ClinicalTrials.gov (NCT04166799). Results: Between January 2020 and May 2022, 266 patients (66%) were randomly assigned to MF and 137 (34%) to standard care. After removing withdrawn patients, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared to standard care (n = 39/251, 15.5%; 95% CI, 11.3-20.6% vs. n = 57/125, 45.6%; 95% CI, 36.7-54.8% respectively, odds ratio [OR]: 0.20, P < .0001). Benefits of MF over standard care remained significant in patients who developed G3 RD (n = 7, 2.8%; 95% CI, 1.1-5.7% vs. n = 17, 13.6%; 95% CI, 8.1-20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9-12.0% vs. n = 24, 19.2%; 95% CI, 12.7-27.1%, OR: 0.36). When evaluating the combined patient and health care professional score using the RISRAS, the MF arm had significantly lower scores than standard care ( P < .0001); individual items on the RISRAS also favored MF for PROs (tenderness, discomfort of pain and burning sensation) and CROs (erythema and moist desquamation). Similarly, when assessed by the SSA, blistering/peeling, erythema, pigmentation, and edema in PROs, and pain/soreness, blistering/peeling, erythema, and pigmentation in CROs were significantly reduced in MF. Topical antibiotics were prescribed significantly less frequently in MF (23.1% vs. 43.2%, P < .0001). Three patients removed the film prematurely due to development of an allergic rash (n = 2) and excessive pruritis (n = 1). Conclusions: MF significantly reduces RD in breast cancer patients undergoing RT when compared to the standard care. We recommend changes to the clinical practice for RD prevention and inclusion of MF in high-risk patients in future guideline recommendations. Clinical trial information: NCT04166799.

Reduction in severity of radiation-induced dermatitis in head and neck cancer patients treated with topical aloe vera gel: A randomized multicenter double-blind placebo-controlled trial.

To assess the efficacy of topical aloe vera gel on radiation induced dermatitis (RID) in head and neck cancer (HNC) patients. In this multicenter randomized double-blind controlled study, HNC patients treated with concurrent chemoradiation (CCRT) received either aloe vera gel or placebo gel. Adverse skin toxicity levels were evaluated with the radiation-induced skin reaction assessment scale (RISRAS). One hundred-twenty patients were enrolled in this study. Analysis of the baseline characteristics did not reveal any differences between the groups. The median RISRAS values from the 1st to the 8th week of the CCRT course were not statistically different between the two groups. In the 5th and 6th weeks of treatment, moderate to severe grades of skin erythematous were observed at values of 13.6% and 24.1% versus 27.8 and 42.6% for members of the aloe vera gel group and the placebo group, respectively (p=0.05 for the 5th week and p=0.038 for the 6th week). In the 7th week, moderate to severe instances of moist desquamation were observed in eight patients (19.0%) in the placebo group (p=0.001). Subjects experienced a burning sensation with RISRAS scores of 3-4 in the 7th week representing only 11.9% of patients in the placebo group (p=0.016). Topical applications of aloe vera gel significantly reduced moderate to severe grades of skin erythematous and instances of moist desquamation in HNC patients receiving CCRT. In this study, there was no prophylactic efficacy for RID in the aloe vera gel group when compared to the placebo group.

Topical use of Jiawei Simiao Yongan Gao to prevent radiodermatitis in patients with head and neck cancer: A retrospective cohort study.

Radiodermatitis is a common side effect of radiotherapy, but currently there is no standard treatment for its prevention. This study aimed to observe the effect of topical application of a paste based on traditional Chinese medicine, Jiawei Simiao Yongan Gao, on radiodermatitis caused by radiotherapy for patients with head and neck cancer.This was a retrospective cohort study of 40 patients with head and neck cancer evaluated during their radiotherapy. Of these, 20 patients were treated with Jiawei Simiao Yongan Gao on the irradiated skin from the beginning of radiotherapy (JSY group). The other 20 patients were given standard nursing (standard group). Acute skin reactions were classified according to the radiation-induced skin reaction assessment scale (RISRAS) and American radiation therapy oncology group (RTOG) acute toxicity grading criteria every 2 weeks, and adverse effects were recorded until the end of the radiotherapy.The two groups showed differences in severity of radiodermatitis. At 0 to 30 Gy, the skin reactions were similar in the two groups, while above 40 Gy the skin reactions were significantly lower grade in the JSY group (P < .05). At 0 to 20 Gy, there was no statistical significance (P > .05); but above 30 Gy they were lower in the JSY group (P < .05).Jiawei Simiao Yongan Gao effectively alleviated acute radiodermatitis caused by radiotherapy of head and neck cancer patients compared with standard nursing.

Mepitel Film is superior to Biafine cream in managing acute radiation-induced skin reactions in head and neck cancer patients: a randomised intra-patient controlled clinical trial.

IntroductionWe previously showed that Mepitel Film decreased the severity of acute radiation‐induced skin reactions in head and neck cancer patients. In the current study, we compared the effect of Mepitel Film and Biafine cream on skin reaction severity in a larger cohort of head and neck cancer patients.MethodsA total of 44 head and neck cancer patients were recruited with 39 patients contributing full data sets for analysis. Patients received a dose of 50 Gy in 25 fractions to the bilateral lymph nodes in the neck. Left and right lymph node areas were randomised to either Mepitel Film or Biafine cream, applied prophylactically. Skin reaction severity was measured using Radiation‐Induced Skin Reaction Assessment Scale (RISRAS) and expanded Radiation Oncology group (RTOG) grades. Skin dose was measured using gafchromic Film.ResultsSkin reaction severity (combined RISRAS score) underneath Mepitel Film was decreased by 30% (P < 0.001) and moist desquamation rates by 41% (P < 0.001). Skin dose underneath Mepitel Film and Biafine cream was similar (P = 0.925) and unlikely to have affected skin reaction severity. The vast majority (80%) of patients preferred Mepitel Film over Biafine cream. Negative aspects of Mepitel Film included poor adherence (11/39) and discomfort (16/39) during hot weather and showering and itchy skin underneath Mepitel Film (12/39).ConclusionsMepitel Film was superior to Biafine cream in reducing the severity of acute radiation‐induced skin reactions and moist desquamation incidence in our head and neck patient cohort.

Effect of Aloe Vera Gel on Severity of Radiation Induced Dermatitis among Patients after Mastectomy

Radiation induced dermatitis is a significant adverse effect of radiation therapy occurring in the majority of patients treated with this modality such as mastectomy. No standard treatment has been recommended for the prevention of this side effect. This article is a report of a study evaluating the effect of Aloe Vera gel on severity of radiation induced dermatitis among patients after mastectomy. A time-series nonequivalent quasi-experimental research design was utilized, hence, a convenient sample of 132 adult female patients receiving radiation therapy after mastectomy were equally assigned randomly to either a study or a control group. Data were collected using two tools: 1) Demographic and Medical Data Sheet, and 2) Radiation Induced Skin Reaction Assessment Scale (RISRAS). The study results revealed statistical significant reduction in radiation induced dermatitis severity scores among the study group compared to the control group. It was concluded that the use of Aloe Vera gel is effective in reducing the severity of radiation induced dermatitis among patients after mastectomy.

Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment.

Radiation-induced skin injury represents the most frequent side effect in breast cancer patients undergoing whole-breast irradiation (WBI). Numerous clinical studies on systemic and topical treatments for radiation dermatitis have failed to provide sustainable treatment strategies. While protective skin products such as dressings are undoubtedly the standard of care in wound care management, their utilization as preventive treatment in radiotherapy has been somewhat neglected in recent years. In this prospective, intra-patient randomized observational study, Hydrofilm polyurethane films were prophylactically applied to either the medial or lateral breast-half of 74 patients with breast cancer undergoing hypofractionated whole-breast irradiation following breast-preserving surgery. Maximum radiation dermatitis severity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 toxicity scores, photospectrometric erythema and pigmentation measurements and patient-assessed modified Radiation-Induced Skin Reaction Assessment Scale (RISRAS) scale. Phantom studies revealed a clinically negligible dose build-up of less than 0.1% with Hydrofilm. Compared to the control compartments physician-assessed radiation dermatitis severity was reduced in the hydrofilm compartments (mean 0.54 vs. 1.34; p = < 0.001). Objective photospectrometric skin measurements showed decreased erythema (p = 0.0001) and hyperpigmentation (p = 0.002) underneath Hydrofilm. Hydrofilm also completely prevented moist desquamation, and significantly reduced patients’ treatment-related symptoms of itching, burning, pain, and limitations of day-to-day-activities. Significant beneficial effects were observed in terms of radiation dermatitis severity, erythema, hyperpigmentation as well as subjective treatment-related symptom experiences, while adverse reactions were rare and minor. Therefore, a prophylactic application of Hydrofilm polyurethane films can be suggested in hypofractionated WBI.

Meta-analysis of self-adhesive soft silicone film dressings on preventing and treating radioactive skin lesion

Objective To systematically assess the effects of self-adhesive soft silicone film dressings on preventing and treating radioactive skin lesion. Methods Randomized controlled trials (RCT) about self-adhesive soft silicone film dressings on preventing and treating radioactive skin lesion were retrieved from PubMed, Web of Science, Cochrane Library, Embase, CNKI, VIP and Wanfang databases, and RevMan 5.3 was used for Meta-analysis of the trials which met the inclusion criteria. Results Totally 10 RCTs were included, with a sample size of 1 231 cases. Meta-analysis revealed that self-adhesive soft silicone film dressings could reducethe incidence of GradeⅡ or above radiodermatitis (OR=0.14, 95%CI 0.08-0.25, P<0.01) , shorten the occurrence time of radiodermatitis within the field of radiotherapy (OR=0.07, 95%CI 0.02-0.32, P<0.01) , and reduce subjective and objective symptom scores of radiodermatitis (Radiation-induced Skin Reaction Assessment Scale, RISRAS) (MD=-3.33, 95%CI-5.96--0.70, P<0.05) . Conclusions Self-adhesive soft silicone film dressings applied on the cutaneous surface within the field of radiotherapy can reduce the severity of radiodermatitis, shorten the occurrence time of radioactive skin lesion within the field of radiotherapy, and effectively ameliorate cutaneous discomfort within the field of radiotherapy and the effects of radiotherapy-induced skin reaction on daily activities. Key words: Radiodermatitis; Self-adhesive soft silicone film dressings; Skin lesion; Malignant neoplasms; Meta-analysis

Prevention of acute radiodermatitis by photobiomodulation: A randomized, placebo-controlled trial in breast cancer patients (TRANSDERMIS trial).

Acute radiodermatitis (RD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the prevention of acute RD in breast cancer (BC) patients undergoing RT. This study was a randomized, placebo-controlled trial including 120 BC patients that underwent an identical RT regimen post-lumpectomy. Patients were randomly assigned to the laser therapy (LT) or placebo group, with 60 patients in each group. Laser or placebo treatments were applied 2 days a week, immediately after the RT session, starting at the first day of RT. PBMT was delivered using a class IV MLS® M6 laser that combines two synchronized laser diodes in the infrared range (808-905 nm) with a fixed energy density (4 J/cm2 ). Skin reactions were scored based on the criteria of the Radiation Therapy Oncology Group (RTOG) and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The patients completed the Skindex-16 questionnaire to evaluate their quality of life. All the measurements were collected at the first day, at a RT dose of 40 Gray (Gy), and at the end of RT (total dose 66 Gy). At a RT dose of 40 Gy, there was no significant difference between the groups in the distribution of RTOG grades. However, at the end of RT the severity of the skin reactions significantly differed between the two groups (P = 0.004), with a larger percentage of patients experiencing RTOG grade 2 or higher (e.g., moist desquamation) in the placebo group (30% vs. 6.7%, for the placebo and laser group, resp.). The objective RISRAS score confirmed these results. In addition, the Skindex-16 and RISRAS subjective score demonstrated that the patients' quality of life was significantly better in the LT than in the control group. The results of this trial show that PBMT is an effective tool to prevent the development of grade 2 acute RD or higher in BC patients. In addition, it also reduces the patients' symptoms related to RD. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc.

Effects of two medicines for prevention of acute radiation skin injury in radiation field among liver cancer patients with Cyberknife therapy

Objective To explore the protective effect of DWK skin protectant and Sanyrene for prevention of acute radiation skin injury in radiation field among liver cancer patients with Cyberknife therapy. Methods A total of 100 liver cancer patients with Cyberknife therapy were selected by convenience sampling from March to November 2016. They were randomly divided into the group of DWK and the group of Sanyrene with 50 cases in each group. Skins in radiation field on hepatic region of patients in two groups used DWK skin protectant and Sanyrene respectively since one day before radiotherapy. The acute radiation skin injury of radiation field on hepatic region was observed from one day before treatment to two weeks the end of treatment during Cyberknife therapy. Results The scores of The Radiation Induced Skin Reaction Assessment Scale (RISRAS) , an instrument for assessing the degree of acute radiation skin injury of radiation field on hepatic region, of patients in two groups increased with the increasing cumulated dose of irradiation with significant differences (F=3.780, 12.325; P<0.05) . There were statistically significant differences in evaluations at the fifth and beyond between two groups (t=5.213, 12.437, 16.846; P<0.05) . Conclusions Intervention for local prevention can alleviate the acute radiation skin injury in radiation field on hepatic region among liver cancer patients with Cyberknife therapy. The protective effect of DWK skin protectant on skin in radiation field on hepatic region among liver cancer patients with Cyberknife therapy is better than that of Sanyrene. Key words: Liver neoplasms; Cyberknife; Radiation damage; Skin protection

Psychological stress affects the severity of radiation-induced acute skin reactions in breast cancer patients

Psychological stress exacerbates many pathological conditions including inflammatory skin conditions. The effect of psychological stress on acute radiation-induced skin reactions has not been documented before. Here, we aimed to explore if psychological stress could aggravate skin reaction severity in breast cancer patients. We conducted a secondary analysis of patient data obtained during a randomised, controlled clinical trial for acute radiation-induced skin reaction severity in 78 breast cancer patients. Patients were assessed three times a week during treatment. Skin reaction severity was measured using the modified Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and Radiation Therapy Oncology Group grades. Stress levels were determined using a 5-point LIKERT scale to rate physical well-being, managing stress levels, house, family, work and other commitments. A total of 20 patients (26%) of the 78-patient cohort were considered stressed. Skin reaction severity in stressed patients was twice that of non-stressed patients (p<0.001) and stressed patients were five times more likely to develop moist desquamation. Our results show that psychological stress aggravates skin reaction severity during radiation therapy. This research needs to be validated in a more rigorous manner by incorporating a validated scale such as the Distress Thermometer and Impact Thermometer in future skin trials.

Randomized Intra-patient Controlled Trial of Mepilex Lite Dressings versus Aqueous Cream in Managing Radiation-Induced Skin Reactions Postmastectomy

Objective: Severe acute radiation-induced skin reactions occur in a significant proportion of women who receive radiation therapy for breast cancer. We previously showed that Mepilex Lite dressings decreased the severity of erythema. Here we report their effect on the full range of skin reactions in 74 breast cancer patients post-mastectomy. Methods: A total of 80 women were recruited from four hospitals in New Zealand with 74 women contributing a full data set for analysis. The first skin area on the chest wall to develop erythema was randomly divided into two similar halves; one half was treated with Mepilex Lite dressings, the other half with aqueous cream. Skin reactions were assessed using the Radiation-Induced Skin Reaction Assessment Scale. Results: Compared with aqueous cream, Mepilex Lite dressings did not significantly reduce the incidence of moist desquamation but did reduce the overall severity of skin reactions by 41% (p<0.001), the average moist desquamation score by 49% (p=0.043) and the sum of the moist desquamation time for all patches by 28% from 25 to 18 weeks. Most patients preferred the dressings, found them easy to use and very comfortable to wear.

Mepilex Lite dressings for the management of radiation-induced erythema: a systematic inpatient controlled clinical trial

Erythema occurs in 80-90% of women treated for breast cancer with radiation therapy. There is currently no standard treatment for radiation-induced skin reactions. This study investigates the clinical efficacy of Mepilex Lite dressings in reducing radiation-induced erythema in women with breast cancer. A total of 28 patients were recruited; of these, 24 participants presented with 34 erythematous areas of skin for analysis. When erythema was visible, each affected skin area was randomly divided into two similar halves: one half was treated using Mepilex Lite dressings, the other half with standard aqueous cream. Skin reactions were assessed by the Radiation-Induced Skin Reaction Assessment Scale. We also evaluated any potential dose build-up by the dressings using a white water phantom, the dose distribution over the breast via thermoluminescent dosimeters (TLDs) and the surface skin temperature with an infrared thermographic scanner. Mepilex Lite dressings significantly reduced the severity of radiation-induced erythema compared with standard aqueous cream (p <0.001), did not affect surface skin temperature and caused only a small (0.5 mm) dose build-up. TLD measurements showed that the inframammary fold was exposed to significantly higher doses of radiation than any other breast region (p <0.0001). Mepilex dressings reduce radiation-induced erythema.

Radiation-induced skin reactions. 3: Evaluating the RISRAS.

This article, the last in a three-part series, reports the methods used to evaluate the Radiation-induced Skin Reaction Assessment Scale (RISRAS), along with the results. For a newly developed tool, the results of the elementary reliability and validity testing were satisfactory. The RISRAS could be used in clinical practice following revision and further development and its introduction into clinical oncology practice is recommended as it will improve the assessment process of radiation-induced skin reactions and lead to better care for those patients undergoing radiotherapy. In the first article in the series (Vol 8(17): 1134-40), the extensive nature of radiotherapy-induced skin reactions were reported, along with their significance for the patient undergoing radiotherapy. Previously described assessment scales were examined in preparation for the development of the RISRAS. In the second article (Vol 8(18): 1208-11), the need for holistic yet specific assessment of these reactions was demonstrated and the methods used to develop the RISRAS were described.

Radiation-induced skin reactions. 2: Development of a measurement tool.

Radiation-induced skin reactions occur commonly in clinical practice and cause various problems for the patient. Assessment and treatment of these reactions is an important part of the healthcare professional's role in the radiotherapy unit. To accomplish this effectively a specific, yet comprehensive, measuring tool is needed. The first article in this three-part series (Vol 8(17): 1134-40) examined the phenomenon of radiation-induced skin reactions, including descriptions of how radiotherapy affects the skin and the prevalence and significance of these skin reactions. Using the literature, the most common signs and symptoms were isolated. This provided the basis for the development of a specific yet holistic assessment tool. In this article, an explanation of the methods used to collect and analyse data for the development of an assessment tool to measure radiation-induced skin reactions is described. The tool is called the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). In the third article in the series, the results of RISRAS's initial evaluation is reported along with its efficacy for clinical practice.

Radiation-induced reactions. 1: An examination of the phenomenon.

In this article, the first in a series of three, the author examines the phenomenon of radiation-induced skin reactions. This includes a description of the theoretical aspects of radiation and its effect on the skin, the prevalence and significance of skin reactions seen in clinical practice and a summary of the assessment tools that have been used in their evaluation. From this information, an analysis of the key signs and symptoms of radiation-induced skin reactions is presented. These clinical indicators and descriptors are then available to be used as the basis for the development of a comprehensive yet specific assessment tool. In part two, these descriptions are integrated into an assessment tool to measure radiation-induced skin reactions and the radiation-induced skin reaction assessment scale (RISRAS) is described. In part three the methods and results from the initial evaluation of the RISRAS are reported.