I Feel Like a Virgin Again After Radiation

Groundwork: Most of the patients who have been treated by mail service-mastectomy radiotherapy (PMRT) feel pare toxicity. At that place have been few studies on acute radiation dermatitis in breast cancer patients who received hypofractionation PMRT. Methods: 62 patients were randomized to receive a general skin care regimen with or without the addition of an emulsion of olive oil and calcium hydroxide twice a day, from the initiation of PMRT to 2 weeks after radiotherapy. Adverse pare reactions and the Skindex-16 score were assessed. Results: At the eighth, 13th, and 16th fraction of PMRT, grade 1 dermatitis was found in 42, 90, and ninety% of the control group and in 16, 30, and 71% of the intervention group. At the cease of the written report, the mean Skindex-sixteen score of the intervention grouping was significantly meliorate than that of the control grouping (p = 0.019). Conclusions: Addition of an emulsion of olive oil and calcium hydroxide for patients undergoing hypofractionation PMRT yielded superior preventive results over a full general skin care regimen solitary, in terms of delaying pare toxicity, reducing the severity of acute radiation dermatitis, and a meliorate quality of life in the intervention group. However, a larger number of patients volition be required to confirm this result.

© 2019 Due south. Karger AG, Basel

Introduction

The acute skin reaction from mail-mastectomy radiotherapy (PMRT) includes erythema, epilation, dry out and moist desquamation, ulceration, and skin necrosis [i,2,3,4,5]. These side effects take been experienced by most patients (74-100%) over the course of their PMRT [half dozen,7]. Porock et al. [eight] reported several predictive factors for the severity of radiation dermatitis, including chest size, age, tumor stage, weight, skin cancer, smoking, lymphocele aspiration, and radiation dose. Moreover, Tucker et al. [9] institute that historic period, genetic predisposition, chronic diseases, skin types, and skin damage from previous cytotoxic chemotherapy play a role in radiosensitivity.

The physiopathology of radiations dermatitis is known to exist a combination of the production of free radicals, which is the main factor for the endothelial jail cell and basal layer cell injury and the inflammatory response. Impecuniousness of the endothelial cells produces a perivascular inflammatory infiltration nearby blood vessels. Deprivation of the basal layer cells involves an inflammatory pour by the transcription of pro-inflammatory cytokines [6,8,9] and is related to skin erythema, which was usually seen in the first ii weeks of irradiation. Moist desquamation, which was seen in the later weeks of irradiation, resulted from the loss of basal layer cells of the epidermis.

The most important role in the management of radiations dermatitis is prophylaxis. Based on the evidence, the Supportive Care Guidelines Group [10] has developed recommendations for the full general pare intendance for patients receiving radiotherapy. The recommendations are: to gently launder the irradiated area with h2o alone, to pat dry out with a soft bath towel, not to apply any topical agents before receiving radiotherapy (as they may have bolus effects and increase the skin dose), to avoid exposure to sunlight and extreme temperatures, to avoid using any metal-based topical products, due east.g. aluminum-based products or zinc oxide topical pastes (equally they also could increment the skin dose), to avert tight clothing over the irradiated skin to prevent friction wounds, and to go along the irradiated skin dry out and make clean.

Owen et al. [11] reported the chemistry and physiological function of olive oil, which has antioxidant and anti-inflammatory backdrop. Ichihashi et al. [12] constitute that daily topical use of olive oil later sunday tanning may defer and subtract ultraviolet light(UV)-induced pare cancer due to decreased levels of the reactive oxygen species-induced 8-hydroxydeoxyguanosine that is responsible for genetic mutations. Kiechl-Kohlendorfer et al. [13] too demonstrated that daily awarding of olive oil could decrease the risk of dermatitis during the report catamenia in all gestational-age infants and that information technology was better than a h2o-in-oil emollient cream. The effect of olive oil in the prophylaxis of acute radiations-induced dermatitis has been reported in nasopharyngeal cancer patients treated with concurrent chemoradiotherapy, and application of this product tin significantly reduce the severity of this adverse event [14].

The upshot of an emulsion of olive oil and calcium hydroxide on the prophylaxis of acute skin reaction from a hypofractionation radiotherapy regimen has non however been studied. The main objective of this trial was to investigate the effect of prophylactic use of 1 detail emulsion in preventing acute skin reactions in patients receiving adjuvant hypofractionation PMRT. The secondary objective was to assess the quality of life (QoL) by using the validated Skindex-16 questionnaires at the same time as the clinical assessments.

Materials and Methods

This randomized study was conducted from August 2016 to April 2017. The written report protocol was approved by our institution's ethics committee. All participants had given their written informed consent. The eligibility criteria included being at to the lowest degree xviii years old and having histologic proof of invasive breast carcinoma and undergoing adjuvant hypofractionation PMRT. The patient must too have a good (Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1). We excluded those patients who had inflammatory carcinoma of the breast likewise equally those with a known allergy to olive oil or calcium hydroxide. Patients with pre-existing loss of skin integrity or prior radiotherapy to the expanse being treated were also excluded. The patients were randomized to either the command group or the intervention group. A block randomization was conducted by computer and there was no stratification for the randomization. The randomization ratio was ane:ane. After receiving a declaration of a new enrollment form from the research nurse, the report statistician referred to the list of randomized numbers and assigned the patient to the next number. Both groups of patients were advised by the protocol nurse to follow the recommendations of the general skin intendance regimen. For the intervention group, the patients were also instructed to use an emulsion of olive oil and calcium hydroxide on the irradiated skin every morning and evening from day ane of the PMRT to 2 weeks after finishing the PMRT. To permit for absorption and to preclude any bolus event of residuum product on the skin, irradiation was not introduced until at least 1 h afterwards production application. All patients were laid on a fly board (CIVCO, Coralville, IA, U.s.) with both arms upwardly above the head. Images from the computed tomography (CT) simulation were transferred into the treatment planning system with Pinnacleⁱⁱⁱ version vii.6 (Philips, Andover, MA, U.s.) or TomoTherapy Hi-Art software, version iv.2.iii (TomoTherapy Inc., Madison, WI, USA). The patients were irradiated to the chest wall and supraclavicular lymph nodes using a 6-MV photon beam for iii-dimensional conformal radiotherapy (3D-CRT). The patients needing to receive the whole axilla irradiation were treated by helical tomotherapy. The patients were treated with a dose of 265 cGy per fraction: 5 fractions per calendar week to a full of dose of 42.4 Gy. For 3D-CRT, a x-mm-thick bolus (Superflab; Med-Tec, Orange, IA, United states) was used just in the start 8 treatment fractions. The maximum dose (D_max) in the irradiated volume, the chest wall separation, and the skin dose that was estimated from the treatment plan were recorded for each patient. Physical examination was performed once every calendar week during the radiotherapy. At the 3rd, 8th, 13th, and 16th fraction and at 1 month subsequently completion of the PMRT, radiation-induced peel toxicity was assessed past the physician using the Radiations Therapy Oncology Group (RTOG) acute radiation morbidity scoring criteria [15]. RTOG grade 0 astute skin toxicity is described as no change, grade ane as follicular erythema, dry out desquamation, epilation, grade 2 as patchy moist desquamation confined to skin folds, grade 3 as confluent moist desquamation of other than skin folds, and class 4 every bit ulceration, hemorrhage, necrosis.

All patients were assessed for QoL by using the validated Skindex-16 questionnaires (Thai version) concurrent with the clinical assessments. These questionnaires have scores ranging from 0 to 96 (for best QoL to poor QoL). In each calendar week of evaluation for the intervention group, the corporeality of the production used was examined by the protocol nurse.

Fisher's exact test was used to compare the distribution of all baseline characteristics between the two written report groups for qualitative variables and the Wilcoxon rank-sum test was used for continuous variables. Fisher's exact test was likewise used to see the statistical significance of the divergence in proportion to the RTOG grades between the ii arms of the study. A probability value of less than 0.05 was considered meaning. The Skindex-16 scores at all the fourth dimension points between both artillery were adjusted to normal distribution by log transformation and are reported every bit geometric mean (GM) and 95% confidence interval. GM Skindex-16 scores were compared using repeated-measures mixed-model analysis. The assumptions of abiding variance and normality of the residuals mistake were examined past visual inspection. All statistical analyses were done with SPSS (version 20) and STATA (version 10.1).

Results

Patient and treatment characteristics were like between the two written report groups (table 1). 62 patients (31 in each grouping) met the inclusion criteria and were enrolled in this trial. The median age and interquartile range were 55 (47-62) years in the control group and 56 (51-61) years in the intervention group. All patients received 16 fractions of hypofractionation PMRT. The radiation fields covered the breast wall and supraclavicular lymph nodes in 21 patients (68%) of the control group and 22 patients (71%) of the intervention group. 10 patients (32%) and 9 patients (29%) from the control and the intervention groups, respectively, received chest wall plus supraclavicular and whole-axilla lymph node irradiation past helical tomotherapy machine. Most of the patients received previous adjuvant anthracycline-based chemotherapy, except for 3 patients who received only adjuvant hormonal treatment during PMRT. None of the patients received adjuvant trastuzumab during PMRT. At the third fraction of treatment, there were only 3 patients (x%) in the control group who developed RTOG course 1 radiation dermatitis whereas there was none in the intervention group (p = 0.238). At the 8th, 13th, and at the concluding fraction of treatment (fraction 16), grade i dermatitis increased to 42, 90, and 90% for the command group and 16, xxx, and 71% for the intervention group as shown in effigy 1; these differences were significant with p-values of 0.049, 0.001, and 0.007, respectively. At the 6-week follow-upward visit post PMRT, there was still significantly fewer form 1 dermatitis in the intervention group than in the control group, i.e.eighteen patients (58%) versus 28 patients (ninety%) (p = 0.002) (fig. 1).

Tabular array one

Patient and handling characteristics

Fig. one

RTOG scores (%) of astute skin toxicity in the control and intervention group over the treatment period and at the 6-week visit.

Breast cancer stage, adjuvant chemotherapy earlier PMRT, radiotherapy technique, pare dose, maximum dose, and chest wall separation were not significant prognostic factors for acute radiations-induced skin reaction.

For the patient-reported outcomes, the GM Skindex-16 score of the intervention group was slightly higher than that of the control group, only the difference was not statistically significant, as shown in table 2. The GM Skindex-16 score of the intervention group decreased significantly from two.42 (3rd fraction) to ane.03 (6-week visit) with a p-value of 0.002. In the control grouping, the GM Skindex-16 score tended to increase over the treatment period and 6-week visit. The GM Skindex-16 score of the control group at the 6-calendar week visit (two.73) was significantly higher than at the 3rd fraction (ane.28) with a p-value of 0.006. At the 6-calendar week visit, the GM Skindex-16 score of the control group was significantly greater than that of the intervention group with a p-value of 0.019 (table 2).

Table 2

Skindex-sixteen scores of all time points between command and intervention

From the safety and tolerability aspects, none of the patients in the intervention group experienced any side furnishings of this product. Only one patient reported a temporary tingling sensation later on applying the emulsion. All the same, this patient connected to participate in the study.

Discussion

Radiation-induced dermatitis is the mutual event in patients receiving radiation therapy. Acute radiations dermatitis changes are a issue of direct tissue injury along with local inflammation [6,8,ix]. The clinical manifestation ranges from balmy erythema to moist desquamation and ulceration. Chronic pare injury usually develops more 3 months after radiotherapy and includes alterations of the vessels and connective tissue of the dermis and underlying subcutaneous tissue [16]. Autonomously from basic skin care provided in the guideline [10], several topical medications and skin care products had been investigated for the prophylaxis and amelioration of acute radiations dermatitis. Salvo et al. [17] investigated the studies of products for the prevention and handling of acute skin reaction from radiotherapy. Most of the studies were categorized every bit prophylactic trials. The intensity of radiation dermatitis was significantly decreased by several corticosteroids in topical class, simply there was no definite suggestion of any favorite corticosteroid [18,19,twenty,21]. There were many studies of non-steroidal pare creams, e.g. hyaluronidase-based creams, Biafine foam, and Aloe vera cream [22,23,24,25,26,27,28]. The evidence for the use of these topical products is inconsistent. Until now, there is no sufficient show to propose the apply of whatever private agent for the prophylaxis of astute radiation dermatitis.

The main mechanism of radiations skin injury involves the production of free radicals and the reduction of antioxidant capacity [29]. Antioxidant agents have been studied in the management of radiation dermatitis in breast cancer [30,31]. Aysan et al. [30] revealed that the application of a boron-based gel significantly macerated the radiations dermatitis compared to placebo in breast cancer patients. Zhao et al. [31] also demonstrated that topical epigallocatechin-3-gallate was well tolerated and effective in treating radiation dermatitis in patients receiving PMRT. Olive oil was selected for our study because it has been used as a skin care production for a long time. Not only does information technology moisturize the pare by preventing transepidermal water loss, but information technology likewise has antioxidant properties [eleven]. The antioxidative components of olive oil include phenolic compounds, tocopherol, squalene, and triterpenic acids [32]. Yet, the antioxidant backdrop of olive oil diminish with time and are markedly decreased subsequently the refining process [33,34]. Neutralization is one of the refining methods that remove undesirable complimentary fatty acids, caused by the hydrolysis of triacylglycerols. Sodium hydroxide has been used as a neutralizing agent to eliminate gratuitous fat acids. Nevertheless, this procedure besides removes natural antioxidants. Using calcium hydroxide instead of sodium hydroxide revealed that oil neutralized with calcium hydroxide had a college amount of α-tocopherol and phytosterols compared to oil neutralized with sodium hydroxide [33]. Our study used an emulsion of virgin olive oil neutralized with calcium hydroxide, which contained loftier amounts of antioxidants. This emulsion also had no fragrance and preservatives, ensuring a depression risk of skin irritation as well as contact allergy.

Topical olive oil was studied by Cui et al. [14] in the prophylaxis of acute radiation toxicity in nasopharyngeal cancer patients treated with radiotherapy plus chemotherapy. Their results indicated that olive oil is an effective and safety prophylactic treatment for radiation-induced dermatitis. Our results lucifer their findings.

Focusing on the 2 patients who had grade 2 toxicity in the last fraction of PMRT, both of them were in the control grouping and received the 3D-CRT technique with bolus to the whole chest wall area in the first half of the treatment. i patient still had grade 2 radiations dermatitis at the time of follow-up. Nevertheless, she had much recovered, with only a small area of moist desquamation being seen in her axilla region. Peel dose, maximum dose, and breast wall separation in these 2 patients were reviewed, and they were not different from those of the other patients in the study. Placing the bolus at the final session of the treatment or omitting information technology at whatsoever fraction, based on a clinical decision, were the options to reduce the skin toxicity. Although our study used a hypofractionation regimen that was supposed to instigate more pare toxicity, nosotros observed a lower incidence of radiations dermatitis compared to the 100% of all patients in the study of Cui et al. [fourteen], which reported some degree of erythema, dry or wet desquamation, or edema, past the end of handling. One of the explanations could be the college-dose radiotherapy (70 Gy) and the implementation of concurrent chemotherapy in their study. Comparable to the report of Cui et al. [xiv], nosotros found the RTOG grade ane radiation dermatitis in the group treated with the emulsion of olive oil and calcium hydroxide to be statistically significantly lower than in the general pare care recommendation group at the 6-week follow-upwardly visit subsequently PMRT. The effectiveness of the olive oil emulsion in protection against pare toxicity might exist explained by the report of Owen et al. [xi], where the antioxidative and anti-inflammatory furnishings of olive oil were reported. All the same, to the best of our knowledge, there are no guidelines on pare toxicity stating that the second layer of the peel cannot exist protected past whatever foam or oil.

In our report, the Skindex-16 was used to measure health-related QoL with skin conditions. This questionnaire is a standard, validated instrument for assessing health-related QoL and is ordinarily used in dermatologic research [35]. It also has more than details to evaluate skin symptoms of patients compared to the more widely used Dermatology Life Quality Index (DLQI). The patient-reported outcome of our study revealed that application of the emulsion of olive oil and calcium hydroxide had an bear on on the astute radiation-induced skin injury compared to the patients who used a general skin care recommendation.

Our randomized prospective report was the offset report using the emulsion of olive oil in hypofractionation radiotherapy. Still, there are a few limitations to our study. First, this written report was unblinded and non-placebo controlled, which may take affected the QoL results. Another limitation was the small sample size to explain individual differences in skin radiosensitivity. A larger number of patients and a confirmatory randomized control trial are required to determine the efficacy of this regimen.

In decision, using an emulsion of olive oil in add-on to general skin care recommendations is associated with a meaning reduction in the intensity of acute radiation-induced skin reaction, deferment of the skin toxicity, and enhancement of a better QoL for breast cancer patients treated with hypofractionation PMRT.

Acknowledgement

The emulsion of olive oil in this written report was supported past Ouiheng International Healthcare Company, Bangkok, Thailand. The authors admit the contributions of the patients and radiation therapists' teams at Chiang Mai University for their assistance.

Disclosure Statement

No conflicts of interest.

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