What Is the Appropriate Skin Cleaning Method for Nasopharyngeal Cancer Radiotherapy Patients? a Randomized Controlled Trial

Abstract Purpose To determine the effect of various cleaning methods for skin with acute radiation dermatitis (RD) in patients treated for nasopharyngeal carcinoma (NPC). Methods A total of 168 NPC inpatients were randomized, while 152 patients completed the whole trial and the data were analyzed. Patients were randomly divided into non-washing group, washing with water alone group, and washing with water and soap group. All three groups received intensity modulated radiation therapy (IMRT) among other treatments. Follow-up from recruitment or the initial radiotherapy dose to 1 month after the final radiotherapy dose. CONSORT checklist was applied as the reporting guidelines for this study. Study evaluated a range of endpoints including incidence, timing, severity of acute RD and quality of life (QOL).Results There were no allergic reactions or aggravating in both washing groups during the whole treatment. The incidence of acute RD was 100% in all three groups, while the degree of severity differed among groups. Washing moderately reduced severity compared with patients without washing; washing also delayed the onset time of acute RD, reduced the incidence of moist desquamation and pruritus. There were no significant difference among groups with respect to pain or burning sensation. Washing improved QOL on physical, emotional, and social functional dimensions. Washing with water and soap was the most effective on reducing itching and improving QOL among three groups. Conclusion Washing irradiated skin reduces the occurrence and severity of acute radiation dermatitis.Clinical trial information ChiCTR2000038231, date of registration 09.18.2020

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A Multicenter Randomized Trial of Breast Intensity-Modulated Radiation Therapy to Reduce Acute Radiation Dermatitis

Yearbook of Oncology ◽

10.1016/s1040-1741(08)79260-1 ◽

2009 ◽

Vol 2009 ◽

pp. 19-20

Author(s):

C.A. Lawton

Keyword(s):

Radiation Therapy ◽

Randomized Trial ◽

Intensity Modulated Radiation Therapy ◽

Acute Radiation ◽

Radiation Dermatitis ◽

Intensity Modulated ◽

Multicenter Randomized Trial

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A Multicenter Randomized Trial of Breast Intensity-Modulated Radiation Therapy to Reduce Acute Radiation Dermatitis

Journal of Clinical Oncology ◽

10.1200/jco.2007.15.2488 ◽

2008 ◽

Vol 26 (13) ◽

pp. 2085-2092 ◽

Cited By ~ 483

Author(s):

Jean-Philippe Pignol ◽

Ivo Olivotto ◽

Eileen Rakovitch ◽

Sandra Gardner ◽

Katharina Sixel ◽

...

Keyword(s):

Radiation Therapy ◽

Randomized Trial ◽

Intensity Modulated Radiation Therapy ◽

Acute Radiation ◽

Radiation Dermatitis ◽

Intensity Modulated ◽

Multicenter Randomized Trial

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Individual Radiosensitivity as a Risk Factor for the Radiation-Induced Acute Radiodermatitis

Life ◽

10.3390/life12010020 ◽

2021 ◽

Vol 12 (1) ◽

pp. 20

Author(s):

Juras Kišonas ◽

Jonas Venius ◽

Olga Sevriukova ◽

Mindaugas Grybauskas ◽

Daiva Dabkevičienė ◽

...

Keyword(s):

Logistic Regression ◽

Risk Factor ◽

Acute Radiation ◽

Radiation Dermatitis ◽

Radiation Toxicity ◽

Skin Reactions ◽

Individual Radiosensitivity ◽

Whole Breast Radiotherapy ◽

Significant Difference ◽

Acute Skin Reactions

Background: Up to 95% of irradiated patients suffer from ionizing radiation (IR) induced early skin reaction, acute radiation dermatitis (ARD). Some experts think that additional skin hydration can reduce acute skin reactions. Individual radiosensitivity (IRS) determined from lymphocytes may help to predict acute radiation toxicity. The purpose of this study is to evaluate the clinical manifestation of ARD in different skincare groups during whole breast radiotherapy depending on IRS and other risk factors. Methods: A total of 108 early-stage breast cancer patients were randomized into best supportive care (BSC) and additional skincare (ASC) groups. IRS was evaluated using a G2 assay modified with caffeine-induced G2 checkpoint arrest. All patients received a 50 Gy dose to the breast planning target volume (PTV). Clinical assessment of ARD symptoms according to the CTCAE grading scale was performed once a week. Results: IRS was successfully determined for 91 out of 108 patients. A total of 10 patients (11%) had normal IRS, 47 patients (52%) were categorized as radiosensitive, and 34 (37%) as highly radiosensitive. There was no significant difference in the manifestation of ARD between patient groups by skincare or IRS. According to logistic regression, patients with bigger breasts were prone to more severe ARD (p = 0.002). Conclusions: The additional skincare did not improve skin condition during RT. A total of 89% of patients had increased radiosensitivity. IRS determined before RT did not show the predictive value for the manifestation of ARD. Logistic regression revealed that breast volume was the most significant risk factor for the manifestation of ARD.

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The effect of various dilute administration of rocuronium blomide on both vascular pain and pharmacologic onset: A randomized controlled trial

10.21203/rs.2.250/v2 ◽

2019 ◽

Author(s):

Mayuko Kanazawa ◽

Aiji Sato(Boku) ◽

Yoko Okumura ◽

Mayumi Hashimoto ◽

Naoko Tachi ◽

...

Keyword(s):

Evaluation Method ◽

Controlled Trial ◽

Muscle Relaxation ◽

Onset Time ◽

Significant Difference ◽

Large Vein ◽

Group 3 ◽

Group 2 ◽

Vascular Pain ◽

Group 1

Abstract Background Rocuronium bromide (RB) is known to cause vascular pain. Although there have been a few reports that diluted administration causes less vascular pain, there have been no studies investigating diluted administration and the onset time of muscle relaxation. Therefore, we examined the influence of diluted administration of RB on the onset time of muscle relaxation and vascular pain. Methods 51 patients were randomly assigned to three groups: RB stock solution 10 mg/ml (Group 1), two-fold dilution 5 mg/ml (Group 2), or three-fold dilution 3.3 mg/ml (Group 3). After the largest vein of the forearm was secured, anesthesia was induced by propofol and 0.6 mg/kg of RB was administered. The evaluation method devised by Shevchenko et al. was used to evaluate the degree of vascular pain. The time from RB administration until the maximum blocking of T1 by TOF stimulation was measured. Results There was no significant difference in escape behaviors of vascular pain among the three groups, and the onset time of muscle relaxation was significantly slower in Group 3 than in Group 1 (p=0.033). Conclusion Our results suggested that it is unnecessary to dilute RB before administration if a large vein in the forearm is used. Trial Registration UMINCTR Registration number UMIN000026737 Registered 28 Mar 2017

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Soft Tissue Response to Titanium Abutments with Different Surface Treatment: Preliminary Histologic Report of a Randomized Controlled Trial

BioMed Research International ◽

10.1155/2016/2952530 ◽

2016 ◽

Vol 2016 ◽

pp. 1-7 ◽

Cited By ~ 1

Author(s):

Luigi Canullo ◽

Jan Friedrich Dehner ◽

David Penarrocha ◽

Vittorio Checchi ◽

Annalisa Mazzoni ◽

...

Keyword(s):

Soft Tissues ◽

Controlled Trial ◽

Tissue Response ◽

Polymorphonuclear Neutrophil ◽

Control Group ◽

Neutrophil Granulocytes ◽

Study Results ◽

Significant Difference ◽

Soft Tissue Response ◽

Cleaning Methods

The aim of this preliminary prospective RCT was to histologically evaluate peri-implant soft tissues around titanium abutments treated using different cleaning methods. Sixteen patients were randomized into three groups: laboratory customized abutments underwent Plasma of Argon treatment (Plasma Group), laboratory customized abutments underwent cleaning by steam (Steam Group), and abutments were used as they came from industry (Control Group). Seven days after the second surgery, soft tissues around abutments were harvested. Samples were histologically analyzed. Soft tissues surrounding Plasma Group abutments predominantly showed diffuse chronic infiltrate, almost no acute infiltrate, with presence of few polymorphonuclear neutrophil granulocytes, and a diffuse presence of collagenization bands. Similarly, in Steam Group, the histological analysis showed a high variability of inflammatory expression factors. Tissues harvested from Control Group showed presence of few neutrophil granulocytes, moderate presence of lymphocytes, and diffuse collagenization bands in some sections, while they showed absence of acute infiltrate in 40% of sections. However, no statistical difference was found among the tested groups for each parameter (p>0.05). Within the limit of the present study, results showed no statistically significant difference concerning inflammation and healing tendency between test and control groups.

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Correlated factors of acute oral mucosal and skin reaction induced by radiotherapy in hypopharyngeal carcinoma

10.21203/rs.3.rs-20081/v1 ◽

2020 ◽

Author(s):

Wang Yan ◽

Xiaoxu Lu ◽

Rong Huang ◽

Tianyuan Li ◽

Tian Tang ◽

...

Keyword(s):

Multivariate Analysis ◽

Total Dose ◽

Skin Reaction ◽

Older Age ◽

Acute Radiation ◽

Smoking History ◽

Radiation Dermatitis ◽

Hypopharyngeal Carcinoma ◽

Significant Difference ◽

Acute Reaction

Abstract Background This present retrospective single center study was intended to investigate the factors associated with acute radiation oral mucositis or dermatitis during hypopharyngeal carcinoma radiotherapy.Methods From May 2012 to December 2018, previously untreated 93 patients with hypopharyngeal squamous cell carcinoma received radiotherapy in Affiliated Cancer Hospital of Zhengzhou University were enrolled. Radiation Therapy Oncology Group (RTOG) scoring criteria were used for assessing the severity of toxicities. Patients are therefore classified into “mild reaction group” (G0~G1) and “acute reaction group” (G2~G4). Single variate was applied to screen out factors with significant difference between mild and acute reaction groups, multivariate analysis was used to detect independent risk factors from those related. A total of 16 medical and laboratory indexes were included to examine, i.e., gender, age, smoking history, primary site, history of hypotension and diabetes, treatment modalities, dose, T (tumor) staging, N (reginal lymph node) staging, as well as hemoglobin value (1 week before radiotherapy). Relevant data used for the study were collected from clinical records.Results Total of 93 subjects completed radiotherapy. Acute mucositis occurred in 75 patients, and 27 cases developed acute radiation dermatitis. Smoking history, post-operative radiotherapy, concurrent chemotherapy, T staging, N staging, total dose (Gy) for GTV, single fraction dose (Gy) for GTV, and hemoglobin value (1 week before radiotherapy) showed significant differences between G0~G1 and G2~G4 groups of oral mucosa reaction; significant differences between mild and acute dermatitis reaction groups were found in diabetes history, hemoglobin value, age, total dose (Gy). Multivariate analysis showed that higher hemoglobin value ( OR = 1.120, P = 0.031), smoking history ( OR = 0.070, P = 0.031) were independent risk factor of acute OM; significant relationships for acute skin reaction were found with hemoglobin value ( OR = 1.059, P = 0.034) and older age ( OR = 1.068, P = 0.036).Conclusion Multivariate analysis showed higher hemoglobin value and smoking history to be the most relevant factors independently predicting grades 2 or higher OM; higher hemoglobin value and older age were found to be significantly associated with acute skin reaction.

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MELADERM-trial: Melatonin cream against acute radiation dermatitis in patients with early breast cancer

Melatonin Research ◽

10.32794/mr11250010 ◽

2019 ◽

Vol 2 (1) ◽

pp. 32-43 ◽

Cited By ~ 1

Author(s):

Dennis Zetner ◽

Claus Kamby ◽

Faisal Mahmood ◽

Jacob Rosenberg

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Radiation Therapy ◽

Early Breast Cancer ◽

Radiation Treatment ◽

Controlled Trial ◽

Acute Radiation ◽

Radiation Dermatitis ◽

Double Blind

Radiation dermatitis following radiation therapy in the treatment of early breast cancer can lead to discontinuation or prolongation of treatment and an impaired quality of life. Melatonin has been demonstrated to protect against radiation injury. The aim of this study is to investigate whether melatonin can protect against radiation dermatitis when applied topically in women receiving radiation therapy for early breast cancer. This study will be a randomized, placebo-controlled, double-blind controlled trial. Patients will apply the melatonin or placebo preparation topically twice daily for the duration of their radiation therapy. Our objective outcomes will be the Radiation Therapy Oncology Group’s acute radiation morbidity scoring criteria for skin, image analysis of clinical photographs, and use of steroid cream for radiation dermatitis. Subjective outcomes will be quality of life questionnaires developed by the European Organisation for Research and Treatment of Cancer. Outcomes will be measured throughout the five weeks of radiation treatment and be followed up for another three weeks. According to sample-size calculations and inclusion schedule, we intend to include a total of 80 evaluable patients. We will analyze the primary outcomes using parametric and non-parametric tests where applicable. Secondary outcomes will be analyzed by a mixed linear model. Most patients with breast cancer who undergo radiation therapy will develop radiation dermatitis as a result of the therapy. Should our intervention provide better outcomes, many patients could obtain a better quality of life. We expect topical melatonin treatment to have little or no adverse effects, to be easy to apply, and not to interfere with the anti-tumor efficacy of the radiation therapy.

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