Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase III Double-Blind, Randomized Trial From the North Central Cancer Treatment Group N06C4

Miller, Robert C.; Schwartz, David J.; Sloan, Jeff A.; Griffin, Patricia; Deming, Richard L.; Anders, Jon C.; Stoffel, Thomas J.; Haselow, Robert E.; Schaefer, Paul; Bearden, James D.; Atherton, Philip J.; Loprinzi, Charles L.; Martenson, James A.

doi:10.1016/j.ijrobp.2010.01.031

Cited by 129 publications

(111 citation statements)

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“…Statistical Power was calculated in RCTs using a two-sided test of significance (8,26,27), test was not reported for in three RCTs (28,29) and no statistical power calculation was present for four (7,(30)(31)(32). Descriptive statistics were reported in all studies for age (quantitative numerical data) including mean, median, and range (7,8,(26)(27)(28)(29)(30)(31)(32)(33). Other trials reported mean and range field size (29,33), field area (33), range of total radiation dose (7,26), median number of nodes and range (8).…”

Section: Methodsmentioning

confidence: 99%

“…Descriptive statistics were reported in all studies for age (quantitative numerical data) including mean, median, and range (7,8,(26)(27)(28)(29)(30)(31)(32)(33). Other trials reported mean and range field size (29,33), field area (33), range of total radiation dose (7,26), median number of nodes and range (8).…”

Section: Methodsmentioning

confidence: 99%

“…The factors used were age, radiotherapy field size and field arrangement and type and number of chemotherapy courses prescribed before radiotherapy. The method of ensuring homogeneity was unclear in other RCTs however the authors stated that the features of the two groups were comparable and balanced (7,8,(26)(27)(28)(29)(30)(31)(32).…”

Section: Methodsmentioning

confidence: 99%

“…The mean maximum score was assessed using a single two-sample t-test (26). The differences in mean responses of patients reported symptoms and Qol were analysed using the Kruskal-Wallis test.…”

Section: Methodsmentioning

confidence: 99%

“…In one of the two studies the Mann-Whitney U-test was used for the statistical analyses of RD and patients reported symptoms (8). In scoring RD observed in participants, a modified RTOG (27), a standard RTOG score (28,(31)(32)(33) and CTCAE version 3.0 was used (26,29). Clinical scales were used in 3 RCTs (7,8,30).…”

Section: Methodsmentioning

confidence: 99%

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Topical Management of Acute Radiation Dermatitis in Breast Cancer Patients: A Systematic Review and Meta-Analysis

Haruna

Lipsett

Marignol

2017

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(OR: 0.29; p<0.0001) and reducing the mean RD score p<0.00001 Radiation induces damage to the skin, activating inflammatory pathways and causing cytokines overproduction (1, 2). Radiation dermatitis is a common acute side-effect that occurs within hours to weeks after the start of radiotherapy (3, 4) and affects more than 87% of patients (2, 5). Radiation dermatitis can limit the therapeutic dose delivered to patients and can, sometimes, lead to a break in treatment, thus potentially compromising local control and survival outcome (1, 6). It can also have a considerable impact on patients' quality of life (7,8). Despite significant development in radiotherapy techniques, efficacious interventions in the prevention of acute skin reactions is still lacking and current evidence is unable to provide adequate guidelines for the management of this sideeffect (9, 10). Studies have examined numerous topical agents such as Aloe Vera, aqueous cream, Calendula, petrolatum and sulcrafate cream as a means to reducing the dehydrating effects of radiation dermatitis (6,11,12). However, the results in terms of managing radiation dermatitis and treatment related pain have not been clinically significant (13,14). Corticosteroids have anti-inflammatory properties and are known to down-regulate cytokine gene expression, making them ideal for managing radiation dermatitis (15-17). A systematic review by Bolderston et al. concluded that there is limited evidence to support or oppose the use of topical agents for the management of acute radiation dermatitis (18).Skin care advice given to breast cancer patients varies among institutions (19). No gold-standard for the appropriate management of this side-effect exists and in most cases the decision of care is left at the discretion of the health care professional rather than clinical evidence (20,21). Clinical advice is often given based on anecdotal evidence (22).The present systematic review and meta-analysis was conducted to assess the potential efficacy of corticosteroids in the management of RD and its impact on pain and quality of life in female breast cancer patients. However, the anticipated adverse effect associated with steroids is not evaluated and is beyond the scope of this review. We restricted our review to one site only due to radiotherapy dose variations used in different sites. Materials and MethodsSearch strategy for identification of studies. The electronic literature search was conducted up to and including March 2017. The search terms used were corticosteroid, radiation dermatitis, breast cancer, management, and prevention. The reference lists of potentially eligible studies were subsequently hand searched to identify 5343

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Topical Management of Acute Radiation Dermatitis in Breast Cancer Patients: A Systematic Review and Meta-Analysis

Haruna

Lipsett

Marignol

2017

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Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy

et al. 2022

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IMPORTANCE Safe and effective prophylactic therapies for radiation-induced dermatitis (RID) remain an unmet need.OBJECTIVE To determine if epigallocatechin-3-gallate (EGCG) solution reduces the incidence of RID in patients undergoing radiotherapy after breast cancer surgery. DESIGN, SETTING, AND PARTICIPANTSThis phase 2 double-blind, placebo-controlled randomized clinical trial enrolled 180 patients with breast cancer receiving postoperative radiotherapy at Shandong Cancer Hospital and Institute in Shandong, China, between November 2014 and June 2019. Data analysis was performed from September 2019 to January 2020.INTERVENTIONS Participants were randomly assigned (2:1) to receive either EGCG solution (660 μmol/L) or placebo (0.9% NaCl saline) sprayed to the whole radiation field from day 1 of the radiation until 2 weeks after radiation completion. MAIN OUTCOMES AND MEASURESThe primary end point was incidence of grade 2 or worse RID, defined by the Radiation Therapy Oncology Group scale. The secondary end points included RID index (RIDI), symptom index, changes in the skin temperature measured by infrared thermal images, and safety.RESULTS A total of 180 eligible patients were enrolled, of whom 165 (EGCG, n = 111; placebo, n = 54) were evaluable for efficacy (median [range] age, 46 [26-67] years). The occurrence of grade 2 or worse RID was significantly lower (50.5%; 95% CI, 41.2%-59.8%) in the EGCG group than in the placebo group (72.2%; 95% CI, 60.3%-84.1%) (P = .008). The mean RIDI in the EGCG group was significantly lower than that in the placebo group. Furthermore, symptom indexes were significantly lower in patients receiving EGCG. Four patients (3.6%) had adverse events related to the EGCG treatment, including grade 1 pricking skin sensation (3 [2.7%]) and pruritus (1 [0.9%]). CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, prophylactic use of EGCG solution significantly reduced the incidence and severity of RID in patients receiving adjuvant radiotherapy for breast cancer. It has the potential to become a new choice of skin care for patients receiving radiotherapy.

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Pruritus

Patel¹,

Yosipovitch²

2013

Dermatologic Principles and Practice in Oncology

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Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase III Double-Blind, Randomized Trial From the North Central Cancer Treatment Group N06C4

Cited by 129 publications

References 30 publications

Topical Management of Acute Radiation Dermatitis in Breast Cancer Patients: A Systematic Review and Meta-Analysis

Topical Management of Acute Radiation Dermatitis in Breast Cancer Patients: A Systematic Review and Meta-Analysis

Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy

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