Abstract
Background/Aim: 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. Patients and Methods: 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. Results: 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). Conclusion: MSC can effectively reduce the severity and delay the onset of RD, while slows down skin moisture decrease during RT.
The incidence of radiation dermatitis in patients with head and neck cancer is as high as 84%, 57% of which are severe T (1) and may lead to treatment interruption, suboptimal tumor response, and even cancer recurrence (2). Infection (3) or severe pain may also occur and reduce patient’s quality of life (4).
Patients with head and neck cancer receiving radiation therapy (RT) are prone to skin erythema after the second week and the situation worsens after the fourth week. The skin may be dry or moist with inflammation (5). The skin discomfort of RT patients increases with the severity of radiation dermatitis, especially itch, burning or stinging, and irritation, which also affect emotions and activities of daily living (6).
There is no universally recognized standard treatment for radiation dermatitis in patients with head and neck cancer (7). However, topically applied products, such as corticosteroids or natural ingredient creams, have been used to protect the skin and promote the repair of radiation dermatitis (8, 9). These products have been shown to reduce the occurrence of severe radiation dermatitis (7). Clinical studies also indicate appropriate skin care can reduce radiation skin reactions and damage (8).
Due to a lack of high-quality large-sample studies and unified assessment criteria for radiation dermatitis, the conclusions of the studies are often contradictory (10). Few studies have focused on the subjective experiences of radiation dermatitis and changes in skin moisture during RT in patients with head and neck cancer. The goal of this study was to establish evidence for the impact of moisturized skin care on the severity of radiation dermatitis.
Patients and Methods
Patient eligibility. The study participants were recruited from the radiation oncology departments of two regional hospitals in the same healthcare system. Newly diagnosed patients with head and neck squamous cell carcinoma confirmed by pathological examination and aged 18 to 80 years who underwent RT were eligible for inclusion. They must also have intact skin without any lesions or abnormalities and no skin defects at the site of surgical reconstruction over the head and neck region. The study was approved by the institutional review board of the participating hospitals (approval letter: IRB-1101106).
Prior to RT, the patients were provided with information about the study and received education on moisturized skin care. They were enrolled in the study only after signing an informed consent form. Patients with open wounds or skin diseases in the RT area, currently using epidermal growth factor receptor monoclonal antibodies, requiring long-term use of immunosuppressive drugs or corticosteroids, and with a BMI (body mass index) of less than or equal to18.5 were excluded from the study.
Study design. Based on the patient’s preference to receive moisturized skin care, the enrolled patients were divided into two groups: the moisturized skin care group and the routine skin care group. The moisturized skin care group received standard pre-RT education along with skin moisturization intervention, while the routine skin care group only received standard pre-RT education.
During the RT course, skin moisture data were collected on a weekly basis using a skin moisture detection device. The skin reactions in the RT area were assessed using the Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and the Radiation Therapy Oncology Group (RTOG) acute skin toxicity grading criteria (Figure 1).
Study scheme.
Radiotherapy. The Pinnacle treatment planning system (Philips Radiation Oncology Systems, Fitchburg, WI, USA) were used and all patients underwent RT using the Synergy® linear accelerator (Elekta AB, Stockholm, Sweden). The choice of radiation technique, including intensity-modulated radiotherapy (IMRT) and volumetric-modulated radiotherapy (VMAT), was based on the physician’s discretion. Concurrent chemotherapy (chemoradiotherapy) was given according to the treatment guidelines of the hospital or conclusions made in multi-disciplinary team meetings.
Standard education for skin care before RT. Standard pre-RT education is provided on the day of RT simulation procedure, focusing on daily skin cleansing, promoting comfort, and preventing skin damage. The details of pre-RT education include:
1. Avoid using cornstarch or talcum powder in skin folds. 2. If hair cutting or shaving is required during the RT, use an electric razor. 3. Avoid exposing the RT area to sunlight and use clothing or hats with brims for sun protection. 4. Wear clothing made of pure cotton or breathable fabrics to reduce friction. 5. Avoid using adhesive tape, hot packing, or wearing necklaces on the head and neck area. 6. Avoid performing vigorous rehabilitation exercises in the RT area.
Moisturized skin care. Apply the skin moisturizer twice daily by gently patting it onto the skin on both sides of the neck. The first application should be performed after each daily RT session, and the second application should be performed in the evening after bathing. Each application of the skin moisturizer was documented with photographs and the remaining amount of the moisturizer was checked on a weekly basis to ensure appropriate use.
Skin moisture cream. In this study, Comfeel® Barrier Cream (Coloplast ANZ, Melbourne, Australia), a skin moisturizer free of fragrances and chemical additives, was used as a skin moisturizing care intervention during RT. The main ingredients are pure water (54.8%), Vaseline (30%), and glycerin (5%). The cream uses water and glycerin for moisture, which is retained by vaseline, to achieve the effect of continuous skin moisturization (11).
Radiation dermatitis evaluation and skin moisture measurement. Patients attend weekly follow-up appointments at the radiation oncology clinic during their RT. Nurses assist in assessing skin condition, measuring skin moisture, and documenting the findings. Skin reactions induced by RT were assessed using the RISRAS and RTOG acute skin toxicity grading criteria. If patients have skin symptoms or signs, appropriate medical interventions are provided based on evidence-based recommendations. The inter-rater reliability coefficient for RISRAS is 0.7, and the intra-rater reliability coefficient is 0.76 (12, 13). RISRAS comprises two parts: part-A evaluates patient’s subjective symptoms using patient-reported scale, while part-B assesses the severity of radiation-induced skin abnormalities through treating team assessment. The scores from both parts are summed to calculate a total score, with higher scores indicating greater severity of radiation dermatitis. The RTOG acute skin toxicity grading criteria are widely used in clinical practice and employ a 5-point scale ranging from 0 to 5, where higher numbers signify increased severity. A score of 3 or above indicates severe radiation dermatitis (14).
Skin moisture levels were measured using the API 100 device (Aram Huvis, Seoul, Republic of Korea). The hospital’s medical engineering department conducts equipment maintenance every three months and calibrates the device before each measurement. The neck area is divided into four quadrants (upper, lower, left, and right), and skin moisture is measured in each quadrant. Environmental humidity is controlled at 50-60%, and the temperature is maintained between 26-28° during measurements. Baseline measurements are obtained during pre-RT education (pretest), and subsequent measurements are taken weekly until two weeks after completing RT (posttest).
Radiation dermatitis management. During RT, if the patient’s skin appears dry and itchy or with occurrence skin reaction symptoms, the radiation oncologist will prescribe steroid cream for topical application twice a day, and monitor patient’s usage by asking the remaining amount of steroid cream. Once moist desquamation occurs, after the wound disinfected, the wound will be applied with a non-sticky silicone dressing to protect the wound; if there is inflammation or discharge implicating bacterial infection, wound culture and antibiotic treatment will be performed.
Statistical analysis. The statistical analysis was conducted using the SPSS software package (IBM Corp. Released 2016. IBM SPSS Statistics for Windows, Version 24.0. IBM Corp., Armonk, NY, USA). Homogeneity analysis of demographic characteristics in the study sample was performed using Chi-square test and t-test. Generalized estimating equations (GEE) were used to examine the differences in patient proportion of skin symptoms and abnormal reactions between the two groups together with time and interaction. Additionally, a mixed effect model analysis was employed to assess differences in the severity of radiation-induced skin reactions and changes in skin moisture between the two groups adjusted for time, dose and interaction of time and group. Sigma Plot version 8.0 (Chicago, IL, USA) was used for generating relevant statistical graphs. Data values are presented as mean±standard error.
Results
Patient characteristics. From November 2021 to May 2023, a total of 54 patients were enrolled in this study, with 27 patients in the moisturized skin care group and 27 patients in the routine skin care group. However, two patients transferred to other hospitals before the start of RT, another two had treatment interruption due to worsening of their diseases, and an additional one died in the middle of the RT course at a nursing institution due to suspected air way obstruction. Finally, a total of 49 patients completed the study and the collected data were included in the statistical analysis (Figure 2).
Patient enrollment.
Patients in this study had an average age of 58.1 years (ranging from 44 to 79 years). Most participants were male, accounting for 43 individuals (87.8%, p=0.01). The most common primary site was oral cancer, with a total of 34 patients (69.4%), followed by nasopharyngeal cancer (12.2%), hypopharyngeal cancer (8.2%), and oropharyngeal cancer (6.1%). There were 20 patients (38.7%) with at least one comorbidity. The average prescribed radiation dose was 6218 cGy (ranging from 5,000 to 7,000 cGy) and the lower neck had less cumulative dose than the upper neck. Among the patients, 25 (61%) received treatment using the IMRT technique, while 24 (49%) received treatment using the VMAT technique. A total of 43 patients (87.8%) received concurrent chemotherapy. Before the start of RT, the average pretest skin moisture on the right upper neck was 29.43% (ranging from 10 to 46%), on the left upper neck was 31.78% (ranging from 15 to 69%), on the right lower neck was 32.29% (ranging from 15 to 60%), and on the left lower neck was 33.98% (ranging from 15 to 74%). There were no significant differences in skin moisture between different skin care groups (Table I).
Baseline characteristics of the patients.
Radiation dermatitis. The total score of RISRAS (Figure 3A) increased significantly over time, and the total score of the moisturized skin care group was significantly lower than that of the routine skin care group (B=0.814, 95%CI=0.121-1.506, p=0.021). In addition, the rate of increase in the total score of the moisturized skin care group was significantly lower than that of the routine skin care group (B=−0.384, 95%CI=−0.656 to −0.111, p=0.006) (Table II).
Radiation dermatitis assessment. Radiation-Induced Skin Response Assessment Scale (RISRAS) was used for assessment before radiation therapy (RT) and weekly thereafter until 2 weeks after completion. (A) RISRAS Total score. (B) RISRAS Part-A (patient symptom scale) score. (C) RISRAS Part-B (healthcare professional assessment scale) score.
Results of radiation dermatitis evaluation.
According to the RTOG acute skin toxicity grading criteria, there were six cases of severe radiation dermatitis in the routine skin care group with higher percentage (26.1%) in comparison to four cases in the moisturized skin care group (15.4%). No significant difference was found between the two groups (Chi-square test p=0.588).
In the first part of RISRAS (part-A, patient symptom scale), there was no significant difference in subjective perception scores between the two groups (B=0.062, 95%CI=−0.282-0.406, p=0.722). As treatment time lapsed, the subjective perception scores of patients showed a positive correlation and increased (p<0.001). However, the scores of the moisturized skin care group were consistently lower than those of the routine skin care group (Figure 3B). We further divided the patients into asymptomatic (1 point) and symptomatic (2-4 points) according to the scores of subjective perception items (i.e., pain, itch, burning, and activity of daily living) (Figure 4A-D). There were no significant differences between the two groups in terms of symptom presentation (Table III). Except for the burning sensation in the second week (Figure 4C), the proportion of patients with symptoms in the moisturized skin care group was lower than that in the routine skin care group at other time points (Figure 4A, C, and D).
Symptomatic patient percentage in each skin care group. Patients were divided according to RISRAS part-A score into asymptomatic (1 point) and symptomatic (2-4 points). (A) Symptomatic patients with pain. (B) Symptomatic patients with itch. (C) Symptomatic patients with burn. (D) Symptomatic patients with their activities of daily living (ADL) affected.
Results of generalized estimating equation (GEE) for symptoms and skin abnormalities.
In the second part of RISRAS (part-B, healthcare professional assessment scale), there were significantly different scores of radiation-induced skin abnormality severity between the two groups (B=0.742, 95%CI=0.305-1.179, p<0.001). The skin reaction scores also increased with time, and the score of the moisturized skin care group was significantly lower than that of the routine skin care group since the fifth week after RT (Figure 3C). We again divided the patients into no skin reaction (0 point) and abnormal skin reaction (1-4 points) according to the scores of skin abnormality items (i.e., erythema, dry desquamation, and moist desquamation) (Figure 5A-C). Although there is no significant difference in the incident proportion of skin reactions between the two groups in each skin abnormality item (Table III), the proportion both dry and moist desquamation in the moisturized skin care group was lower than that in the routine skin care group (Figure 5B and C), except for the proportion of moist desquamation in the third week after RT (Figure 5C).
Percentage of patients with abnormal skin reaction in each skin care group. Patients were divided according to RISRAS part-B score into no skin reaction (0 point) and abnormal skin reaction (1-4 points). (A) Patients with erythema. (B) Patients with dry desquamation. (C) Patients with moist desquamation. E: Erythema; DD: dry desquamation; MD: moist desquamation.
Skin moisture. There was no significant difference in the average skin moisture among the four quadrants of the neck between the two groups before RT (Table I), and Table IV also shows no significant difference between the two groups during RT (right upper neck: B=−2.037, 95%CI=−7.074-3.001, p=0.424; left upper neck: B=−3.475, 95%CI=−8.426-1.512, p=0.171; right lower neck: B=1.373, 95%CI=−3.640-6.385, p=0.589; left lower neck: B=0.939, 95%CI=−4.429-6.308, p=0.73). The number of weeks lapsed after RT was negatively correlated with the change of skin moisture (Figure 6), which means that as RT proceeded or treatment time increased, the skin moisture decreased significantly (p<0.001). As the number of weeks lapsed after RT increased, there was a significant difference between the two groups in the rate of decrease in skin moisture of both right upper quadrants of the neck (p=0.007) and left upper quadrants of the neck (p=0.018) (Table IV). The moisturized skin care group had slower skin moisture decreasing rate than the routine skin care group. After each week during RT, the average skin moisture decrease in the right upper/left upper necks was −0.27/−0.66 and −1.21/−1.59 for the moisturized skin care group and routine skin care group, respectively. However, the skin moisture decreasing rate did not differ at bilateral lower quadrants of the neck.
Results of mixed effect model analysis for skin moisture by four quadrants.
Skin moisture assessment. Skin moisture changes in the four quadrants of the neck were measured before RT and weekly thereafter until 2 weeks after completion. Cumulative dose unit was centigray (cGy). (A) Routine skin care group. (B) Moisturized skin care group.
Discussion
This study found that as the RT course progressed, the skin moisture decreased and moisturized skin care could maintain higher skin moisture and significantly slow down the rate of skin moisture decline in comparison with routine skin care group (Table IV), while delaying onset and severity of radiation dermatitis (Figure 3A), particularly dry desquamation, in which the benefits of moisturized skin care are the most evident (Figure 3C).
As the RT cumulative dose increased, the skin moisture of the routine skin care group in the left and right neck regions gradually decreased starting from the second week (Figure 6A). However, the moisturized skin care group exhibited a rising trend in skin moisture during this time (Figure 6B). A study suggested that persistent skin reactions occur between 2-4 weeks after RT (8). Others have indicated that the cumulative dose of RT is a risk factor for decreased skin moisture, and there is a negative correlation between skin moisture and the severity of acute radiation dermatitis (7). In this study, although skin moisture continued to decline with the progression and cumulative dose of RT, the intervention of moisturized skin care effectively mitigated the decrease in skin moisture of bilateral upper necks (Table IV) and consequently delayed the onset of radiation dermatitis (Figure 3). Bilateral lower neck skin moisture decreasing rate did not differ between the skin care groups. The reason for this result may be the reduced cumulative radiation dose over the lower neck (Table I) but mandates further validation.
Although there was no statistically significant difference in skin moisture between the two groups, the analysis within each group found that compared with the baseline value of skin moisture before RT, in the moisturized skin care group, the skin moisture rose steadily two weeks after RT and the decline in skin moisture did not reach a significant difference until the 6th week (Figure 6B). However, in the routine skin care group the trend of skin moisture decline persisted after RT and was significantly different earlier than in the moisturized skin care group at the 4th week (Figure 6A). Evaluation of the interval changes in skin moisture values, can help to assess whether the patient has indeed followed the moisturized skin care instructions. We can discuss skin moisture value decline with the patient to ensure their better compliance with the moisturized skin care practice.
While there was no statistically significant difference in subjective RISRAS scores between the groups (Figure 3B), the intragroup analysis revealed that patients in the routine skin care group experienced itching and burning sensations as early as the first week after RT, whereas the moisturized skin care group had lower symptomatic patient proportion (Figure 4B and C), indicating lower severity at the same time point. These subjective symptoms are associated with skin barrier damage, as studies have shown that RT can lead to atrophy of sebaceous glands, resulting in the production of proteolytic enzymes and inflammatory cytokines. This further contributes to increased moisture loss through the epidermis and alteration of the skin’s pH, which can occur during the latent phase of radiation-induced skin damage (15).
The observed delayed occurrence of subjective discomfort and lower RISRAS scores in the moisturized skin care group (Figure 3B) may suggest reduction in latent phase skin barrier damage. However, the RISRAS scores for pain, itching, and burning sensations did not show significant improvement with moisturized skin care. This may contribute to the impact on patients’ daily activities at 6-7th week after RT (Figure 4D). Despite the use of topical steroid prescribed by radiation oncologist while skin reaction symptoms occurred, symptomatic patients still comprised up to 40% of moisturized skin care group. The reason for this may be so called “corticophobia” among Taiwanese (16). Therefore, it is worth investigating whether the topical use of natural compounds can further improve the subjective skin discomfort.
In this study, it was observed that female patients showed better self-care and willingness to comply with moisturized skin care, while male patients were less willing to apply moisturizers (Table I). Male patients with a better caregiving support system were more likely to adhere to moisturized skin care. Previous research has also indicated that patient compliance with non-pharmacological interventions is greatly influenced by their health literacy (17). Therefore, it is reasonable to infer that male patients who refused moisturized skin care in the routine skin care group may have had lower health literacy level. Finally, it should be noted that this study was not a randomized controlled trial and may be susceptible to uncontrolled confounding factors that could influence the results.
Conclusion
Moisturized skin care can effectively reduce the severity of radiation dermatitis and delay its occurrence, while slow down the decline in skin moisture during RT. Therefore, it is recommended that patients with head and neck cancer undergoing RT proactively engage in moisturized skin care, before experiencing a decline in skin moisture.
Acknowledgements
The Authors would like to thank Chang Bing Show Chwan Memorial Hospital for the research project funding support (BRD-111015) and the directors and colleagues of the radiation oncology departments of Show Chwan Healthcare System at Changhua, as well as the case manager of Cancer Administration and Coordination Center for their assistance at Show Chwan Memorial Hospital. The Authors would also like to thank the research assistance center (RAC) of Show Chwan Healthcare System and Chiou-Fang Liou assistant professor of Chung Shan Medical University for his assistance and guidance in statistics.
Footnotes
Authors’ Contributions
Pei-Chuan Tsai, Yu-Chang Liu, and Tzong-Shiun Li carried out the experiments. Fei-Ting Hsu, Yuan-Hao Lee, I-Tsang Chiang, and Yuan Chang wrote the manuscript. Yu-Chang Liu and Chiu-Hsiang Lee helped supervise the project. Yu-Chang Liu and Chiu-Hsiang Lee conceived the original idea and supervised the project.
Conflicts of Interest
This research received financial support only from institutional research project and has not accepted any sponsorship from manufacturers.
- Received June 19, 2023.
- Revision received July 22, 2023.
- Accepted July 24, 2023.
- Copyright © 2023, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved
This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY-NC-ND) 4.0 international license (https://creativecommons.org/licenses/by-nc-nd/4.0).
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