mometasone-furoate and Radiodermatitis

Topics: Breast Neoplasms; Double-Blind Method; Emollients; Female; Humans; Iran; Lawsonia Plant; Mometasone Furoate; Radiodermatitis

Acute radiation dermatitis (ARD) is a common adverse effect in patients undergoing radiotherapy. Mometasone furoate cream (MMF) was reported to significantly reduce ARD, especially in breast cancer. Clinically, ARD is more critical and more difficult to prevent in patients with head and neck squamous cell carcinoma (HNSCC) than in those with breast cancer, because a higher dose of radiotherapy is required in HNSCC cases. The aim of this study was to evaluate the effect of MMF local application on radiation dermatitis in patients with HNSCC.. HNSCC patients scheduled for bilateral radical radiotherapy to the neck with identical radiation doses were enrolled. One side of the neck skin (test groups) of the patients were randomized to apply a thin layer of MMF once a day from the date of first radiotherapy until either 2 weeks after end of radiotherapy or until the test side skin developed ARD lesions, while the other side of neck (control groups) didn't apply any medication. The severity of ARD was evaluated weekly by using the modified radiation therapy oncology group score, pain intensity, and itch stages.. Forty-one patients (82 targets) were analyzed. There was a significant difference between the ARD scores on the test side and the control side. MMF reduced the stages of ARD when the radiotherapy dose was <6000 cGY (P = .01) but showed no improvement when the dose was ≥6000 cGY (P = .699). Compared to the control side, local application of MMF significantly reduced the itch and pain scores of the test side skin regardless of the radiotherapy dose and ARD stage (P < .001) during radiotherapy.. This study showed that MMF inunction after high-dose radiotherapy (>50 Gy) can prevent ARD, especially when the radiation dose is <6000 cGY.

Topics: Administration, Cutaneous; Adult; Aged; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Humans; Middle Aged; Mometasone Furoate; Prospective Studies; Radiodermatitis; Self Care; Skin Cream; Young Adult

A 2-arm, double-blinded randomized trial was conducted to evaluate the efficacy of 0.1% mometasone furoate (MF) versus Eucerin Original (E) cream in preventing the development of moderate to severe acute radiation dermatitis (ARD) in breast cancer patients receiving postmastectomy radiation (PMRT).. Breast cancer patients undergoing chest wall with or without nodal radiation therapy (RT) (50 Gy) were eligible. Randomization (1:1) was to MF or E, applied twice daily from day 1 of PMRT to 14 days after PMRT. Patients were stratified by RT technique, body mass index, and reconstruction status. Daily bolus of 3 to 10 mm was applied in all patients. The primary endpoint was the development of provider-assessed grade ≥2 (Common Terminology Criteria for Adverse Events version 4.03) ARD with moist desquamation or any grade ≥3 dermatitis. Secondary endpoints were time to occurrence of maximum-grade dermatitis and patient-reported skin symptoms using a skin-related quality of life questionnaire, Skindex-16. Assessments were performed at baseline, weekly during PMRT, and 2 weeks after PMRT.. 124 patients were enrolled between May 2013 and February 2016. Of those, 35% had pathologic stage III disease, 6% had cT4d disease, and 68% underwent reconstruction. Sixty percent received 3-dimensional conformal RT with photons only to the chest wall, 18% received electrons and photons, and 23% received inverse-planned intensity modulated RT. Groups were well balanced for age, skin type, and stage. The rate of moist desquamation was 54.8% in the entire cohort, with a significantly reduced incidence in the MF arm than in the E arm (43.8% vs 66.7%; P = .012). The MF arm had a lower incidence of maximum skin toxicities (P = .036) and longer time to development of grade 3 dermatitis (46 days vs 35.5 days, respectively; P ≤ .001). There was no difference in patient-reported skin outcomes between arms.. Breast cancer patients receiving MF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Breast Neoplasms; Dermatologic Agents; Double-Blind Method; Female; Humans; Lipids; Mastectomy; Middle Aged; Mometasone Furoate; Ointment Bases; Postoperative Care; Quality of Life; Radiodermatitis; Thoracic Wall; Treatment Outcome

Evidence on the prevention of radiation dermatitis is lacking. The aim of this study was to investigate the effect of 3M Cavilon No Sting Barrier Film and topical corticosteroids on irradiated skin.. Thirty-nine postoperative breast cancer patients were randomized into three groups for intraindividual comparison (skin to be irradiated was divided into 2 parts): (1) 3M No Sting Barrier Film versus no treatment; (2) corticosteroid versus no treatment; and (3) corticosteroid versus 3M No Sting Barrier Film. The primary end points monitored were the time to first occurrence of grade 1 pruritus, pain score of 3 and grade 2 radiation dermatitis. The secondary end points studied were the incidence of grade 3 radiation dermatitis and total pain scores. Data analysis was done using the SPSS software version 10.. Skin given the 3M barrier film experienced a later occurrence of pruritus compared to both corticosteroids and untreated, although this was statistically insignificant. Corticosteroids delayed the time to occurrence of grade 2 dermatitis compared to both untreated skin and 3M barrier film, (mean day of onset = corticosteroid: 52 vs. untreated: 43, p = 0.092; corticosteroid: 53.4 vs. 3M barrier film: 44.5, p = 0.002, t test). Skin given corticosteroids had the lowest incidence of grade 3 dermatitis among all three conditions, although the differences were statistically insignificant. No statistically significant differences were noted in total pain scores.. The 3M barrier film may be helpful against dermatitis associated pruritus. Corticosteroids may delay the time of onset of severe skin reactions and also reduce the incidence of severe radiation dermatitis.

Topics: Adrenal Cortex Hormones; Adult; Aged; Breast Neoplasms; Female; Humans; Middle Aged; Mometasone Furoate; Radiodermatitis; Radiotherapy; Taiwan; Treatment Outcome

We wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study (Boström et al, Radiother Oncol 2001;59:257-265).. The study was a double-blind comparison of MF with D (Diprobase), administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy, 40 Gy in 2.67-Gy fractions daily over 3 weeks. The primary endpoint was mean modified Radiation Therapy Oncology Group (RTOG) score.. Mean RTOG scores were significantly less for MF than for D (P=.046). Maximum RTOG and mean erythema scores were significantly less for MF than for D (P=.018 and P=.012, respectively). The Dermatology Life Quality Index (DLQI) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression (HAD) questionnaire scores.. MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy. For the first time, we have shown a significantly beneficial effect on quality of life using a validated instrument (DLQI), for a topical steroid cream. We believe that application of this cream should be the standard of care where radiation dermatitis is expected.

Topics: Administration, Topical; Breast Neoplasms; Dermatologic Agents; Dose Fractionation, Radiation; Double-Blind Method; Drug Administration Schedule; Emollients; Erythema; Female; Humans; Middle Aged; Mometasone Furoate; Pregnadienediols; Radiodermatitis; Sample Size; Skin Cream

A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy.. Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy.. A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002).. Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Dermatologic Agents; Double-Blind Method; Female; Humans; Middle Aged; Mometasone Furoate; Pregnadienediols; Pruritus; Radiodermatitis

Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider-assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs.. Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: <0.5, mild; 0.5-0.7, moderate; and >0.7, strong.. CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness.. The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash, redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity.

Topics: Breast Neoplasms; Communication; Dermatologic Agents; Erythema; Female; Humans; Mometasone Furoate; Outcome Assessment, Health Care; Pregnadienediols; Prospective Studies; Pruritus; Quality of Life; Radiodermatitis; Treatment Outcome

Radiation-induced dermatitis is a very common side effect of radiation therapy, and may necessitate interruption of the therapy. There is a substantial lack of evidence-based treatments for this condition. The aim of this study was to investigate the effect of mometasone furoate cream (MMF) on radiation dermatitis in a prospective, double-blind, randomized study.. The study comprised 49 patients with node-negative breast cancer. They were operated on with sector resection and scheduled for postoperative radiotherapy using photons with identical radiation qualities and dosage to the breast parenchyma. The patients were randomized to receive either MMF or emollient cream. The cream was applied on the irradiated skin twice a week from the start of radiotherapy until the 12th fraction (24 Gy) and thereafter once daily until 3 weeks after completion of radiation. Both groups additionally received non-blinded emollient cream daily. The intensity of the acute radiation dermatitis was evaluated on a weekly basis regarding erythema and pigmentation, using a reflectance spectrophotometer together with visual scoring of the skin reactions.. MMF in combination with emollient cream treatment significantly decreased acute radiation dermatitis (P=0.0033) compared with emollient cream alone. There was no significant difference in pigmentation between the two groups.. Adding MMF, a potent topical corticosteroid, to an emollient cream is statistically significantly more effective than emollient cream alone in reducing acute radiation dermatitis.

Topics: Acute Disease; Administration, Topical; Aged; Anti-Inflammatory Agents; Breast Neoplasms; Double-Blind Method; Emollients; Female; Follow-Up Studies; Glucocorticoids; Humans; Middle Aged; Mometasone Furoate; Pregnadienediols; Radiodermatitis; Radiotherapy; Treatment Outcome; World Health Organization

Topics: Allantoin; Breast Neoplasms; Dermatologic Agents; Emollients; Female; Humans; Male; Mometasone Furoate; Pregnadienediols; Radiodermatitis; Skin Cream

Historically, skin toxicity has been assessed in prospective clinical trials using the clinician-reported National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). The patient-reported Skindex-16 measures symptoms and perceptions of toxicity. This study was designed to compare information provided by these two measures.. Data were compiled from three placebo-controlled North Central Cancer Treatment Group studies (N06C4, N03CB, N05C4) having rash prevention as the primary objective. All used the Skindex-16 and CTCAE at baseline, weekly during treatment and during a minimum 2-week follow-up period. Statistical procedures, including Pearson correlations, were utilized to determine relationships between adverse event (AE) grades and Skindex-16 scores.. Four hundred and twelve individual patients provided data (median age, 61; 134 male). Patients' Skindex-16 score results show a 0.9 overall mean (range 0-6 with 6 being worse symptoms), a 0.4 baseline mean (range, 0-4.3) and a 1.3 end-of-treatment mean (range, 0-5.9). Ninety-three, 142 and 177 patients experienced a grade 0, 1 and 2+ CTCAE skin toxicity, respectively. Baseline Skindex-16 scores had relatively low correlation with CTCAE grades. The correlation of rash grade with Skindex-16 scores ranged from r = 0.49 with the function subscale to r = 0.62 with the symptom subscale. The highest correlations of the maximum grade of any dermatological AE with the Skindex-16 were r = 0.48 for the total score and r = 0.55 for the symptom subscale.. The data reported support the decision to include both measures in a clinical trial to assess the patient experience, as each measure may specifically target varying symptoms and intensities.

Topics: Algorithms; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Agents; Breast Neoplasms; Cetuximab; Erlotinib Hydrochloride; Exanthema; Female; Gefitinib; Humans; Male; Middle Aged; Mometasone Furoate; Neoplasms; Pregnadienediols; Protein Kinase Inhibitors; Protein Synthesis Inhibitors; Quinazolines; Radiodermatitis; Randomized Controlled Trials as Topic; Severity of Illness Index; Sunscreening Agents; Surveys and Questionnaires; Terminology as Topic; Tetracycline