Prevention Of Radiation Dermatitis Research Articles

Bacterial Decolonization to Prevent Radiation Dermatitis

Bacterial Decolonization to Prevent Radiation Dermatitis

Radiodermatitis - review of treatment options

Abstract Radiation dermatitis is one of the commonest side effects of ionizing radiation which is applied in radiotherapy of carcinoma of all localizations, most frequently of tumors of breast, head and neck region, lungs and soft tissue sarcomas. It usually occurs as a complication of breast radiotherapy and thus it is more often recorded in female patients on the skin in the region of breast subjected to radiation. Clinical manifestations of radiation dermatitis can be divided into four phases: acute phase (erythema, dry desquamation, moist desquamation, ulceration and necrosis with resulting re-epithelialization, residual post-inflammatory hyperpigmentation, reduction and suppression of sebaceous and sweat glands and epilation); subacute phase (hyperpigmentation and hypopigmentation, telangiectasia, skin atrophy, even ulceration); chronic phase (skin atrophy, dermal fibrosis and permanent skin epilation) and late phase (increased risk of skin cancer). In order to prevent radiation dermatitis, skin care products should be applied throughout radiotherapy that will decrease the frequency of skin reactions or block them and thus improve life quality. Although the therapy includes not only topical corticosteroids but numerous other products with active ingredients such as aloe vera, calendula, hyaluronic acid, sucralfat, sorbolene, mineral and olive oil, honey, vitamin C, zinc, antimicrobials and silver, common therapeutic consensus has not been reached on their application in radiation dermatitis. Therefore, the treatment should be conducted according to the basic guidelines but tailor-made for each individual patient.

Protective Effect of Punica granatum Extract in Head and Neck Cancer Patients Undergoing Radiotherapy.

In India, head and neck cancers account for 30-40% cancers of all sites. Due to lack of screening program, wide variation in the availability of infrastructures and expertise, patients present at an advanced stage. The main stay of management of the head and neck tumours is surgery and chemoradiation. Radiation dermatitis and mucositis is one of the most common side effect encountered during the radiotherapy. Aim of our study was to study protective role of pomegranate extract on radiation induced dermatitis and mucositis in head and neck cancer patients. It was a prospective, clinical, double blind, case control study. 60 patients (30 active and controls) undergoing radiotherapy for head and neck cancer were studied for 12months. Patients in study group were given whole fruit pomegranate extract. Each capsule contained 300mg of whole fruit extract, each capsule contains 40% polyphenols and 27% punicalagin. Each patient were given 2 capsules every day for a period of 6-7weeks. The skin and mucosal changes was graded according to the acute radiation morbidity scoring criteria (RTOG) for skin and mucous membrane. The results were statistically significant. Pomegranate extract proved to be radioprotective. Our study is one of the first study in humans to demonstrate the effectiveness of pomegranate extract in preventing radiation dermatitis and mucositis.

Prophylactically applied Hydrofilm polyurethane film dressings reduce radiation dermatitis in adjuvant radiation therapy of breast cancer patients

Purpose: Radiation-induced skin injury represents one of the most common side effects in breast cancer patients receiving adjuvant whole-breast radiotherapy. Numerous systemic and topical treatments have been studied in the prevention and management of radiation-induced skin injury without providing sustainable treatment strategies. While superficial barrier-forming skin products such as dressings are the standard of care in wound care management, their utilization as preventive treatment approach in radiotherapy has barely attracted attention.Methods: In this prospective, intra-patient randomized study, Hydrofilm polyurethane film dressings were applied prophylactically to either the medial or lateral breast half of 62 patients with breast cancer undergoing adjuvant radiation therapy following breast conserving surgery. The breast half contralateral to the film dressing was concurrently treated with 5% urea lotion as control skin care. Maximum severity of radiation dermatitis was assessed using RTOG/EORTC toxicity scores, photospectrometric erythema measurements and patient-assessed modified RISRAS scale.Results: In the Hydrofilm compartments, mean maximum RTOG/EORTC radiation dermatitis severity grades were significantly reduced from 1.33 to 0.35 and photospectrometric measurements showed significantly reduced erythema severity, as compared to the control compartments, with an overall response rate of 89.3%. Hydrofilm completely prevented moist desquamation and significantly reduced patients’ subjective experience of itching and pain.Conclusion: The obtained results along with a favorable cost–benefit ratio and an easy and quick application suggest a prophylactic application of Hydrofilm in adjuvant radiotherapy of breast cancer patients to reduce or even prevent radiation dermatitis.

A Randomized Clinical Study of Mometasone Furoate Cream in Prevention of Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma Patients Receiving Radiation Therapy (NCT02495064)

A Randomized Clinical Study of Mometasone Furoate Cream in Prevention of Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma Patients Receiving Radiation Therapy (NCT02495064)

The Efficacy of Licorice Root (Glycyrrhiza glabra) and Yarrow (Achillea millefolium) in Preventing Radiation Dermatitis in Patients with Breast Cancer: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

Background: Radiation dermatitis is one of the most common side effects of radiotherapy for breast cancer, affecting approximately 85 percent of patients. The aim of this study is to assess the effect of Licorice root (Glycyrrhizin glabra) and Yarrow (Achillea millefolium) on preventing radiotherapy-induced dermatitis in breast cancer patients.Methods: Seventy-five patients with breast cancer who had undergone mastectomy and were planned to receive radiotherapy (RT) were enrolled in this randomized, double-blind, placebo-controlled study. The extract of Achillea millefolium and Glycyrrhizin glabra root were incorporated into a vanishing cream base. Patients were randomly divided into three groups and received Glycyrrhizin glabra cream, placebo or Achillea millefolium cream for five weeks during RT. The rate and grade of radiation dermatitis were recorded at baseline, at the end of third week and at the end of treatment using a modified Radiation Therapy Oncology Group (RTOG) grading tool.Results: At the end of the third week, the group receiving Achillea millefolium cream showed milder skin complications than other groups. At the end of treatment, rate of skin complications in groups receiving herbal drugs was lower than placebo group but it was not statistically significant. Conclusions: In conclusion, the results of this study did not present a significant difference between Glycyrrhiza glabra, Achillea millefolium and placebo on preventing radiation dermatitis.

Preemptive treatment with Xonrid®, a medical device to reduce radiation induced dermatitis in head and neck cancer patients receiving curative treatment: a pilot study.

The purpose of this study was to investigate efficacy, safety and tolerability of Xonrid®, a new medical device, in preventing radiation dermatitis associated with head and neck cancer (HNC) radiotherapy (RT). In this monocentric, prospective pilot study, adult consecutive HNC patients who were planned to receive curative RT with or without chemotherapy were enrolled. Patients were instructed to apply Xonrid® on the irradiated area during treatment continuing until 2weeks after the completion of RT or the development of severe skin toxicity. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 scale. The patient reported outcome measures included the Skindex-16 questionnaire and patient satisfaction. Skin reflectance spectra were analyzed to objectively evaluate dermatitis. In total, 41 subjects were enrolled (30 males, median age 60years). No skin adverse events were recorded either in the skin area where the product was applied or in the nearby skin over the entire period of administration. At the end of RT, nine patients (22%) presented G1, 31 (76%) G2, and one patient (2%) G3 skin toxicity (after 5weeks). Seven and 20 patients reached skin maximum toxicity at the fourth week and after the seventh week, respectively. An increasing trend of median spectrophotometry scores along with skin toxicity grades was observed. A correlation between Skindex-16 scores and skin toxicity grade during treatment was found. Our study results suggest that Xonrid® is well tolerated, safe, and effective in minimizing and delaying high-grade radiation dermatitis in HNC patients.

Complete prevention of radiation-induced dermatitis using topical adrenergic vasoconstrictors.

Radiation dermatitis is a commonly occurring, painful, side effect of cancer radiotherapy that causes some patients to withdraw from the radiotherapy course. Our goal was to test and optimize topical application of an adrenergic vasoconstrictor to rat skin in a preclinical test to prevent radiation-induced dermatitis. A radiation dermatitis assay was developed in which 17.2Gy to a 1.5×3.0cm rectangle on the clipped dorsal back of rats yielded Grade 3 radiation dermatitis over the irradiated area 13days later. Single, topical applications of each of three adrenergic vasoconstrictors, epinephrine, norepinephrine, or phenylephrine, in various vehicle formulations, doses, and application schedules, were tested to determine their efficacy in preventing radiation dermatitis. Each of the three adrenergic agonists conferred 100% prevention of radiation dermatitis in linear, dose-dependent manners and their EC50 potencies in preventing radiation dermatitis correlated well with their individual K d association constants for binding to mammalian α-adrenergic receptors. Topical vasoconstrictor application as little as 3-12min before irradiation gave 80-100% prevention, respectively, of radiation dermatitis. There was a strong correlation between the extent (0-100%) of skin blanch present in skin immediately before irradiation and prevention of radiation dermatitis scored 13days after irradiation. The data presented here demonstrate that topical application of adrenergic vasoconstrictors to rat skin before a large, 17.2Gy, radiation insult confers 100% protection against radiation dermatitis and support ongoing clinical trials and commercial development of a vasoconstrictor-based product to prevent radiotherapy-induced dermatitis.

Patient Preference for Instructional Reinforcement Regarding Prevention of Radiation Dermatitis.

Although patient preference is a core value within the context of patient-centered models of care, little attention has been paid to determining patient preference for instructional media. Nurses have traditionally used verbal face-to-face instruction as the mainstay of patient education, with written materials being used extensively as teaching guides to supplement verbal instruction or for instructional reinforcement. However, advances in technology have made possible the adding of video instruction to nurses' repertoire of instructional media. The purpose of this study was to determine patients' media preferences (verbal, video, written) when receiving instructional reinforcement about self-care needed to prevent radiation dermatitis. The current study was conducted as a secondary analysis of data from a process improvement initiative. In the parent study, patients received multimedia education related to skin care to prevent radiation dermatitis. This secondary analysis examined patient preference for verbal, video, or written education reinforcement at treatment weeks 1 and 3. Results suggest that, when given a choice, verbal and video reinforcement are preferred over written reinforcement.

Gel of chamomile vs. urea cream to prevent acute radiation dermatitis in patients with head and neck cancer: a randomized controlled trial.

To compare a gel made with chamomile (Chamomilla recutita) with a cream of urea as an intervention to delay the time to occurrence of radiation dermatitis. Radiation dermatitis is one of the most common adverse effects of radiotherapy in patients with head and neck cancer. It is characterized by erythema, itching, pain, skin breakage and burning sensation, and there is no consensus on how to prevent it. The study is a randomized controlled clinical trial. We will recruit 48 individuals with head and neck cancer who will be starting their radiotherapy and randomize them to receive either gel of chamomile or cream of urea, as an intervention for prevention of radiation dermatitis. Social-demographic data will be collected at baseline, and clinical data will be collected before the initiation of radiotherapy. Participants will be followed weekly to assess development of radiation dermatitis. The protocol is funded by Conselho Nacional de Pesquisa e Desenvolvimento Científico (Brazil). The study was approved by a research ethics committee. Given the clinical relevance of preventing radiation dermatitis and the lack of evidence supporting specific preventive interventions, it is important to study new products that might be efficacious to prevent this complication. This article presents the protocol of a randomized controlled trial comparing a gel made with chamomile (intervention) with a cream of urea (control) to prevent radiation dermatitis in patients with head and neck cancer undergoing radiotherapy.

The Efficacy and Safety of Jaungo, a Traditional Medicinal Ointment, in Preventing Radiation Dermatitis in Patients with Breast Cancer: A Prospective, Single-Blinded, Randomized Pilot Study.

Purpose. This study was performed to evaluate the efficacy and safety of Jaungo in preventing radiation dermatitis in patients with breast cancer. Methods. Thirty patients were prospectively enrolled and randomly assigned to receive Jaungo or general supportive skin care. Radiation dermatitis and pain were examined at daily intervals from the start of radiotherapy until 4 weeks after its completion. The primary endpoint of this study was the incidence of radiation dermatitis. The secondary endpoints were time to onset of radiation dermatitis, duration of radiation dermatitis, and maximum pain score. Results. Jaungo reduced the incidence of grade ≥2 (46.7% versus 78.6%) and grade 3 radiation dermatitis (20.0% versus 50.0%) in comparison with general supportive skin care. Jaungo also delayed the onset of grade 2 dermatitis (35 days versus 30 days). In terms of time to onset of grade 3 dermatitis, duration of dermatitis, and maximum pain score, Jaungo showed results comparable to those achieved with general supportive skin care. No patients experienced adverse effects caused by Jaungo administration. Conclusions. Jaungo minimized radiation dermatitis in patients with breast cancer without causing adverse effects. Further randomized studies with a larger sample size are required to assess clinical use of Jaungo.

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation.

A case-control, mono-center, open-label, pilot study to evaluate the feasibility of therapeutic touch in preventing radiation dermatitis in women with breast cancer receiving adjuvant radiation therapy

Therapeutic touch (TT) is a non-invasive commonly used complementary therapy. TT is based on the use of hand movements and detection of energy field congestion to correct imbalances. Improvement in subjective symptoms in a variety of clinical trials has been seen with TT. The effect of TT during radiotherapy for breast cancer is unknown. Women undergoing adjuvant radiation for Stage I/II breast cancer post conservative surgery were recruited for this cohort study. TT treatments were administered three times per week following radiation therapy. Feasibility was defined as an a priori threshold of 15 of 17 patients completing all TT treatments. The preventive effectiveness of TT was evaluated by documenting the 'time to develop' and the 'worst grade of radiation' dermatitis. Toxicity was assessed using NCIC CTC V3 dermatitis scale. Cosmetic rating was performed using the EORTC Breast Cosmetic Rating. The quality of life, mood and energy, and fatigue were assessed by EORTC QLQ C30, POMS, and BFI, respectively. The parameters were assessed at baseline, and serially during treatment. A total of 49 patients entered the study (17 in the TT Cohort and 32 in the Control Cohort). Median age in TT arm was 63 years and in control arm was 59 years. TT was considered feasible as all 17 patients screened completed TT treatment. There were no side effects observed with the TT treatments. In the TT Cohort, the worst grade of radiation dermatitis was grade II in nine patients (53%). Median time to develop the worst grade was 22 days. In the Control Cohort, the worst grade of radiation dermatitis was grade III in 1 patient. However, the most common toxicity grade was II in 15 patients (47%). Three patients did not develop any dermatitis. Median time to develop the worst grade in the control group was 31 days. There was no difference between cohorts for the overall EORTC cosmetic score and there was no significant difference in before and after study levels in quality of life, mood and fatigue. This study is the first evaluation of TT in patients with breast cancer using objective measures. Although TT is feasible for the management of radiation induced dermatitis, we were not able to detect a significant benefit of TT on NCIC toxicity grade or time to develop the worst grade for radiation dermatitis. In addition, TT did not improve quality of life, mood, fatigue and overall cosmetic outcome.

The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study.

BackgroundThere have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT). We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer.MethodsThirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients’ evaluation of pain within the RT field was also assessed.ResultsIn the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%), five (33.3%), and five patients (33.3%), respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%), nine (47.4%), two (10.5%), and one patient (5.3%), respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%). The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not statistically significant.ConclusionThe results of this study show that laughter therapy can have a beneficial role in preventing radiation dermatitis in patients with breast cancer. To confirm the results of our study, well-designed randomized studies with large sample sizes are required.

Phase III Randomized Pair Comparison of a Barrier Film vs. Standard Skin Care in Preventing Radiation Dermatitis in Women with Breast Cancer Receiving Adjuvant Radiation Therapy

Phase III Randomized Pair Comparison of a Barrier Film vs. Standard Skin Care in Preventing Radiation Dermatitis in Women with Breast Cancer Receiving Adjuvant Radiation Therapy

Oil of Chinese medicine for preventing radiation dermatitis

Objective To explore the preventive measures for radiation dermatitis in cancer patients.Methods 85 cancer patients receiving radiation therapy were randomly divided into an observation group (n=43) and a control group (n=42).Self-made oil of Chinese medicine was smear on the skin of radiotherapy area before the radiotherapy every time in the observation group,while MEBO in the control group.After the radiotherapy,both groups continued the treatment for 3 days,3 times a day.The incidences of radiation dermatitis were observed.Results The incidence of radiation dermatitis was 13.95％,4 cases got grade Ⅰ radiation dermatitis,2 grade Ⅱ,but no grade Ⅲ and Ⅳ in the observaiton group.The incidence of radiation dermatitis 38.09％,7 cases occurred grade Ⅰ radiation dermatitis,6 grade Ⅱ,3 grade Ⅲ,and no grade Ⅳin the control group.There were statistical differences between the two groups(P ＜ 0.05).Conclusion Selfmade oil of Chinese medicine for preventing radiation dermatitis has some effect. Key words: Chinese medicine; Radiation therapy; Dermatitis

Effect of HMB/Arg/Gln on the Prevention of Radiation Dermatitis in Head and Neck Cancer Patients Treated with Concurrent Chemoradiotherapy

This prospective randomized Phase II study was designed to evaluate the preventive effect of an oral nutrition supplement composed of beta-hydroxy-beta-methylbutyrate, arginine and glutamine (beta-hydroxy-beta-methylbutyrate/arginine/glutamine) on radiation dermatitis in head and neck cancer patients. Forty patients with histologically proven head and neck cancer, treated with concurrent chemoradiotherapy involving cisplatin were recruited. They were randomly assigned to the beta-hydroxy-beta-methylbutyrate/arginine/glutamine supplement treatment group (Group A) or the control group that received no supplement (Group B). The primary endpoint of this study was the percentage of patients developing ≥Grade 3 dermatitis. The secondary endpoints were the percentage of patients developing ≥Grade 2 dermatitis, and the duration of each grade of dermatitis relative to the observation period. The incidence of ≥Grade 3 dermatitis did not differ between the two groups. However, as secondary endpoints of this study, the incidence of ≥Grade 2 dermatitis was lower in Group A than B (62.6 vs. 94.4%; P < 0.05), and the duration of ≥Grade 1 dermatitis was shorter in Group A than B (44.8 vs. 56.7%; P < 0.01), as was the duration of ≥Grade 2 dermatitis (16.5 vs. 26.5%; P < 0.05). Our study indicated that beta-hydroxy-beta-methylbutyrate/arginine/glutamine supplementation was potentially effective in the prevention of radiation dermatitis in head and neck cancer patients.

Effect of topical vasoconstrictor exposure upon tumoricidal radiotherapy

Topical application of the alpha adrenergic vasoconstrictors norepinephrine, phenylephrine or epinephrine to skin or mucosa in alcohol:water-based delivery vehicles minutes before irradiation has recently been shown to protect skin and mucosa cells against radiotherapy-induced toxicities in both preclinical and clinical studies. The protective mechanism is thought to involve transient skin or mucosal vasoconstriction with secondary, transient hypoxia and associated radioprotection. Regarding possible protection of tumor cell nests within the radiotherapy field, the endothelial cell-abnormal stroma constructed blood vessels generally found in human tumors commonly lack adrenergic receptor-containing smooth muscle cells that are required to achieve vasoconstriction. Consistent with this, we show here that topical application of norepinephrine or phenylephrine to broken or intact skin over human Cal-27 or A-431 xeonograft, or mouse solid L1210 allograft tumors growing subcutaneously in nude mice, showed no effect upon radiation-induced tumor growth inhibition. Although vasoconstrictor-induced nude mouse skin blanch was seen minutes after topical application of 600 mM norepinephrine, no blanching was seen within the A-431 xenograft tumors. Radiation dermatitis was severe 11 days post-irradiation (2 × 13.8 Gy) in the irradiated field containing xenograft tumors in mice that received topical delivery vehicle, but was absent in mice that received topical norepinephrine. Topical vasoconstrictor-conferred prevention of radiation dermatitis without discernible radioprotection of three histologically diverse xenograft or allograft tumors supports further development of the topical vasoconstrictor therapeutic strategy in humans.

The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: results from a multicenter observational study.

PurposeThis study was designed to evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in cancer patients.Materials and MethodsFrom December 2010 to April 2012, a total of 1,172 cancer patients who received radiotherapy (RT) of more than 50 Gy were prospectively enrolled and treated with EGF-based cream. An acute skin reaction classified according to the Radiation Therapy Oncology Group 6-point rating scale was the primary end point and we also assessed the occurrence of edema, dry skin, or pruritus.ResultsThe percentage of radiation dermatitis with maximum grade 0 and grade 1 was 19% and 58% at the time of 50 Gy, and it became 29% and 47% after completion of planned RT. This increment was observed only in breast cancer patients (from 18%/62% to 32%/49%). Adverse events related to the EGF-based cream developed in 49 patients (4%) with mild erythema the most common. Skin toxicity grade >2 was observed in 5% of the patients. Edema, dry skin, and pruritus grade ≥3 developed in 9%, 9%, and 1% of the patients, respectively.ConclusionProphylactic use of an EGF-based cream is effective in preventing radiation dermatitis with tolerable toxicity. Further studies comparing EGF cream with other topical agents may be necessary.

Abstract B130: Radiodermatitis prevention by topical norepinephrine in post-surgical breast cancer patients

Abstract Purpose: This study was a feasibility and exploratory study to evaluate the safety and efficacy of topical norepinephrine in preventing radiodermatitis in patients receiving whole breast external beam radiation therapy after breast conserving surgery. Materials &amp; Methods: In preclinical experiments to test whether co-application of a topical vasoconstrictor would limit the systemic uptake of a topically applied, radioprotective, oxygen free radical scavenger, it was observed that the vasoconstrictor alone was radioprotective, preventing radiation dermatitis when administered alone as a control. This radioprotection is consistent with a mechanism based on local, transient vasoconstriction within the skin, which reduces local tissue oxygenation, limits the formation of radiation-induced reactive oxygen species, and protects skin stem cells from radiation damage. Topical norepinephrine was well tolerated in two Phase I safety studies conducted prior to this study, one in normal volunteers and one in cancer patients receiving palliative radiation therapy for bone metastases. Tested doses elicited transient skin blanch, which is indicative of reduced blood flow secondary to local vasoconstriction, but did not induce blood pressure elevation, local skin necrosis, or any other significant adverse event. Most of the adverse events that were possibly, probably, or definitely related to study medication were mild skin reactions, typically including pruritis, that occurred at or near the application site. There were no serious adverse events. The present study was a nonrandomized, open-label safety and exploratory study in post-surgical breast cancer patients treated with 45 to 50 Gray to the whole breast. A 10-16 Gray boost to the lumpectomy region was permitted. Eligible patients were women, age 18 years or older, who underwent breast conserving surgery for Stage Ia (T1, N0, M0), Stage Ib (T0 or 1, N1mic, M0) or Stage IIa (T&amp;lt;3cm, N0, M0) infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ (DCIS). The radioprotectant dose was a topical application of 3.0 mL of norepinephrine HCl (82.3 mg/mL in 70% ethanol) applied to the same 50-cm2 treatment site within the lateral aspect of the whole breast radiation field (i.e. in or near the axilla) about 20 minutes prior to each daily radiotherapy fraction. Results: 10 patients completed the protocol. No new safety concerns were identified. There were no serious adverse events, and no occurrences of norepinephrine-associated damage to irradiated skin. Assessments of radiodermatitis severity at the treatment site provided evidence for local reductions in radiodermatitis severity, compared to surrounding (untreated) control areas, in a majority of the treated patients. Conclusions: Topical norepinephrine demonstrated promising preliminary results in reducing radiation dermatitis in women undergoing whole breast irradiation, with minimal toxicity. Dose escalation, an expansion of the dose volume to permit the treatment of the entire skin area at risk for radiodermatitis, will precede a randomized, placebo-controlled evaluation of safety and efficacy. NCT01263366. Citation Format: James F. Cleary, Bethany M. Anderson, Jens C. Eickhoff, Deepak Khuntia, William E. Fahl, Allen L. Thunberg. Radiodermatitis prevention by topical norepinephrine in post-surgical breast cancer patients. [abstract]. In: Proceedings of the AACR Special Conference on Advances in Breast Cancer Research: Genetics, Biology, and Clinical Applications; Oct 3-6, 2013; San Diego, CA. Philadelphia (PA): AACR; Mol Cancer Res 2013;11(10 Suppl):Abstract nr B130.