Radiation Dermatitis

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Toshikatsu Kawasaki - One of the best experts on this subject based on the ideXlab platform.

  • topical steroid versus placebo for the prevention of Radiation Dermatitis in head and neck cancer patients receiving chemoradiotherapy the study protocol of j support 1602 topics study a randomized double blinded phase 3 trial
    BMC Cancer, 2018
    Co-Authors: Sadamoto Zenda, Takuhiro Yamaguchi, Tomoya Yokota, Tempei Miyaji, Tomoe Mashiko, Mari Tanaka, Masahito Yonemura, Misaki Takeno, Tomoka Okano, Toshikatsu Kawasaki
    Abstract:

    To date, the clinical benefit of topical steroid use has only been demonstrated for Radiation Dermatitis induced by 50–60 Gy irRadiation in breast cancer. However, these agents are also often used clinically for the control of Radiation Dermatitis induced by high-dose (>60Gy) irRadiation with chemotherapy in head and neck cancer. Despite this, the prophylactic efficacy of topical steroids for Radiation Dermatitis induced by high-dose irRadiation is still unclear. The aim of this study is to clarify the benefit of topical steroids in basic nursing care for Radiation Dermatitis induced by chemoradiotherapy in patients with head and neck cancer. The study is being conducted as a multicenter 2-arm randomized double-blinded placebo-controlled Phase 3 trial in Japan. The study was started in May 2017, with participant enrollment between May 2017 and April 2019. Patients scheduled to receive definitive or postoperative chemoradiotherapy for head and neck cancer are eligible for enrollment. All patients will receive chemoradiotherapy, consisting of single agent CDDP and 70-Gy irRadiation. Bilateral neck irRadiation is mandatory. Supportive care for Radiation Dermatitis will consist of basic nursing care with topical steroid or placebo. When Radiation Dermatitis grade 1 is seen or total Radiation dose reaches 30 Gy, minimally required intervention will be started as a first step. If Radiation Dermatitis worsens to grade 2, the irradiated area will be covered with a moderately absorbent surgical pad and steroid or placebo topical cream. The primary endpoint is a comparison of the proportion of patients with ≥ grade 2 Radiation Dermatitis by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Ethical approval has been obtained from all participating sites. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences. Evidence supporting the benefit of adding topical steroids in general nursing care for Radiation Dermatitis induced by high-dose irRadiation with chemotherapy is insufficient. This trial aims to clarify the clinical benefit of topical steroid for Radiation Dermatitis induced by high-dose irRadiation with chemotherapy. The trial is ongoing and is currently recruiting. UMIN000027161 . Protocol version 3.0, 18 April 2017.

  • Topical steroid versus placebo for the prevention of Radiation Dermatitis in head and neck cancer patients receiving chemoradiotherapy: the study protocol of J-SUPPORT 1602 (TOPICS study), a randomized double-blinded phase 3 trial
    BMC, 2018
    Co-Authors: Sadamoto Zenda, Takuhiro Yamaguchi, Tomoya Yokota, Tempei Miyaji, Tomoe Mashiko, Mari Tanaka, Masahito Yonemura, Misaki Takeno, Tomoka Okano, Toshikatsu Kawasaki
    Abstract:

    Abstract Background To date, the clinical benefit of topical steroid use has only been demonstrated for Radiation Dermatitis induced by 50–60 Gy irRadiation in breast cancer. However, these agents are also often used clinically for the control of Radiation Dermatitis induced by high-dose (>60Gy) irRadiation with chemotherapy in head and neck cancer. Despite this, the prophylactic efficacy of topical steroids for Radiation Dermatitis induced by high-dose irRadiation is still unclear. The aim of this study is to clarify the benefit of topical steroids in basic nursing care for Radiation Dermatitis induced by chemoradiotherapy in patients with head and neck cancer. Methods The study is being conducted as a multicenter 2-arm randomized double-blinded placebo-controlled Phase 3 trial in Japan. The study was started in May 2017, with participant enrollment between May 2017 and April 2019. Patients scheduled to receive definitive or postoperative chemoradiotherapy for head and neck cancer are eligible for enrollment. All patients will receive chemoradiotherapy, consisting of single agent CDDP and 70-Gy irRadiation. Bilateral neck irRadiation is mandatory. Supportive care for Radiation Dermatitis will consist of basic nursing care with topical steroid or placebo. When Radiation Dermatitis grade 1 is seen or total Radiation dose reaches 30 Gy, minimally required intervention will be started as a first step. If Radiation Dermatitis worsens to grade 2, the irradiated area will be covered with a moderately absorbent surgical pad and steroid or placebo topical cream. The primary endpoint is a comparison of the proportion of patients with ≥ grade 2 Radiation Dermatitis by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Ethical approval has been obtained from all participating sites. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences. Discussion Evidence supporting the benefit of adding topical steroids in general nursing care for Radiation Dermatitis induced by high-dose irRadiation with chemotherapy is insufficient. This trial aims to clarify the clinical benefit of topical steroid for Radiation Dermatitis induced by high-dose irRadiation with chemotherapy. The trial is ongoing and is currently recruiting. Trial registration number UMIN000027161. Protocol version 3.0, 18 April 2017

Chandra F Meghrajani - One of the best experts on this subject based on the ideXlab platform.

  • A randomized, double-blind trial on the use of 1% hydrocortisone cream for the prevention of acute Radiation Dermatitis
    Expert review of clinical pharmacology, 2016
    Co-Authors: Chandra F Meghrajani, Jon G. Arcillas, Clarita C. Maaño, Nonette A. Cupino
    Abstract:

    ABSTRACTBackground: To determine whether the application of 1% hydrocortisone cream during Radiation therapy can prevent the occurrence of moist desquamation.Methods: Fifty adult female breast carcinoma patients were randomized after modified radical mastectomy and chemotherapy to receive prophylactic placebo cream (n = 27) or 1% hydrocortisone cream (n = 23) during Radiation therapy. The patients, caregiver and assessor were all blinded to the treatment received. Occurrence of moist desquamation, severity of acute Radiation Dermatitis (ARD) and hyperpigmentation were evaluated weekly until the end of radiotherapy.Results & conclusion: Five patients in each group developed moist desquamation; however, its extent and severity were milder in the steroid group. Mean ARD scores were also lower in the steroid group (0.713 vs. 0.874, p = 0.024). A lower incidence of Grades 1 and 2 Radiation Dermatitis was also noted in the steroid group at weeks 2 and 4, respectively, indicating prophylactic use of steroids del...

  • Topical corticosteroid therapy for the prevention of acute Radiation Dermatitis: a systematic review of randomized controlled trials
    Expert review of clinical pharmacology, 2013
    Co-Authors: Chandra F Meghrajani, Charlene Marie U Ang-tiu, Francisca C Roa
    Abstract:

    Acute Radiation Dermatitis (ARD) is a common side effect of Radiation therapy and is characterized by erythema, dry desquamation or moist desquamation. This wet desquamation is a very painful condition for the patient and often leads to interruption of radiotherapy. The objective of this article is to assess the efficacy of topical corticosteroids in the prevention of ARD compared with placebo, other topical medication or no treatment. The prophylactic application of topical corticosteroid among patients undergoing radiotherapy appears to significantly reduce the incidence of ARD, specifically moist desquamation, compared with other treatments. Future trials with a more standardized measure of Radiation Dermatitis grading are recommended. Further research may also be conducted to determine if a mildly potent, midpotent or super potent topical steroid will be more effective in preventing ARD.

Francisca C Roa - One of the best experts on this subject based on the ideXlab platform.

  • Topical corticosteroid therapy for the prevention of acute Radiation Dermatitis: a systematic review of randomized controlled trials
    Expert review of clinical pharmacology, 2013
    Co-Authors: Chandra F Meghrajani, Charlene Marie U Ang-tiu, Francisca C Roa
    Abstract:

    Acute Radiation Dermatitis (ARD) is a common side effect of Radiation therapy and is characterized by erythema, dry desquamation or moist desquamation. This wet desquamation is a very painful condition for the patient and often leads to interruption of radiotherapy. The objective of this article is to assess the efficacy of topical corticosteroids in the prevention of ARD compared with placebo, other topical medication or no treatment. The prophylactic application of topical corticosteroid among patients undergoing radiotherapy appears to significantly reduce the incidence of ARD, specifically moist desquamation, compared with other treatments. Future trials with a more standardized measure of Radiation Dermatitis grading are recommended. Further research may also be conducted to determine if a mildly potent, midpotent or super potent topical steroid will be more effective in preventing ARD.

Sadamoto Zenda - One of the best experts on this subject based on the ideXlab platform.

  • topical steroid versus placebo for the prevention of Radiation Dermatitis in head and neck cancer patients receiving chemoradiotherapy the study protocol of j support 1602 topics study a randomized double blinded phase 3 trial
    BMC Cancer, 2018
    Co-Authors: Sadamoto Zenda, Takuhiro Yamaguchi, Tomoya Yokota, Tempei Miyaji, Tomoe Mashiko, Mari Tanaka, Masahito Yonemura, Misaki Takeno, Tomoka Okano, Toshikatsu Kawasaki
    Abstract:

    To date, the clinical benefit of topical steroid use has only been demonstrated for Radiation Dermatitis induced by 50–60 Gy irRadiation in breast cancer. However, these agents are also often used clinically for the control of Radiation Dermatitis induced by high-dose (>60Gy) irRadiation with chemotherapy in head and neck cancer. Despite this, the prophylactic efficacy of topical steroids for Radiation Dermatitis induced by high-dose irRadiation is still unclear. The aim of this study is to clarify the benefit of topical steroids in basic nursing care for Radiation Dermatitis induced by chemoradiotherapy in patients with head and neck cancer. The study is being conducted as a multicenter 2-arm randomized double-blinded placebo-controlled Phase 3 trial in Japan. The study was started in May 2017, with participant enrollment between May 2017 and April 2019. Patients scheduled to receive definitive or postoperative chemoradiotherapy for head and neck cancer are eligible for enrollment. All patients will receive chemoradiotherapy, consisting of single agent CDDP and 70-Gy irRadiation. Bilateral neck irRadiation is mandatory. Supportive care for Radiation Dermatitis will consist of basic nursing care with topical steroid or placebo. When Radiation Dermatitis grade 1 is seen or total Radiation dose reaches 30 Gy, minimally required intervention will be started as a first step. If Radiation Dermatitis worsens to grade 2, the irradiated area will be covered with a moderately absorbent surgical pad and steroid or placebo topical cream. The primary endpoint is a comparison of the proportion of patients with ≥ grade 2 Radiation Dermatitis by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Ethical approval has been obtained from all participating sites. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences. Evidence supporting the benefit of adding topical steroids in general nursing care for Radiation Dermatitis induced by high-dose irRadiation with chemotherapy is insufficient. This trial aims to clarify the clinical benefit of topical steroid for Radiation Dermatitis induced by high-dose irRadiation with chemotherapy. The trial is ongoing and is currently recruiting. UMIN000027161 . Protocol version 3.0, 18 April 2017.

  • Topical steroid versus placebo for the prevention of Radiation Dermatitis in head and neck cancer patients receiving chemoradiotherapy: the study protocol of J-SUPPORT 1602 (TOPICS study), a randomized double-blinded phase 3 trial
    BMC, 2018
    Co-Authors: Sadamoto Zenda, Takuhiro Yamaguchi, Tomoya Yokota, Tempei Miyaji, Tomoe Mashiko, Mari Tanaka, Masahito Yonemura, Misaki Takeno, Tomoka Okano, Toshikatsu Kawasaki
    Abstract:

    Abstract Background To date, the clinical benefit of topical steroid use has only been demonstrated for Radiation Dermatitis induced by 50–60 Gy irRadiation in breast cancer. However, these agents are also often used clinically for the control of Radiation Dermatitis induced by high-dose (>60Gy) irRadiation with chemotherapy in head and neck cancer. Despite this, the prophylactic efficacy of topical steroids for Radiation Dermatitis induced by high-dose irRadiation is still unclear. The aim of this study is to clarify the benefit of topical steroids in basic nursing care for Radiation Dermatitis induced by chemoradiotherapy in patients with head and neck cancer. Methods The study is being conducted as a multicenter 2-arm randomized double-blinded placebo-controlled Phase 3 trial in Japan. The study was started in May 2017, with participant enrollment between May 2017 and April 2019. Patients scheduled to receive definitive or postoperative chemoradiotherapy for head and neck cancer are eligible for enrollment. All patients will receive chemoradiotherapy, consisting of single agent CDDP and 70-Gy irRadiation. Bilateral neck irRadiation is mandatory. Supportive care for Radiation Dermatitis will consist of basic nursing care with topical steroid or placebo. When Radiation Dermatitis grade 1 is seen or total Radiation dose reaches 30 Gy, minimally required intervention will be started as a first step. If Radiation Dermatitis worsens to grade 2, the irradiated area will be covered with a moderately absorbent surgical pad and steroid or placebo topical cream. The primary endpoint is a comparison of the proportion of patients with ≥ grade 2 Radiation Dermatitis by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Ethical approval has been obtained from all participating sites. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences. Discussion Evidence supporting the benefit of adding topical steroids in general nursing care for Radiation Dermatitis induced by high-dose irRadiation with chemotherapy is insufficient. This trial aims to clarify the clinical benefit of topical steroid for Radiation Dermatitis induced by high-dose irRadiation with chemotherapy. The trial is ongoing and is currently recruiting. Trial registration number UMIN000027161. Protocol version 3.0, 18 April 2017

  • A prospective picture collection study for a grading atlas of Radiation Dermatitis for clinical trials in head-and-neck cancer patients.
    Journal of radiation research, 2016
    Co-Authors: Sadamoto Zenda, Yosuke Ota, Hiroyuki Tachibana, Hirofumi Ogawa, Shinobu Ishii, Chikako Hashiguchi, Tetsuo Akimoto, Yuichiro Ohe, Yosuke Uchitomi
    Abstract:

    Radiation Dermatitis is one of the most common acute toxicities of both radiotherapy and chemoradiotherapy. Many clinical trials have evaluated the level of toxicity using the Common Terminology Criteria for Adverse Events ver. 4.03. This criterion accounts for severity in a single sentence only, and no visual classification guide has been available. Thus, there is a risk of subjective interpretation by the individual investigator. This contrasts with the situation with hematologic toxicities, which can be interpreted objectively. The aim of this prospective picture collection study was to develop a grading tool for use in establishing the severity of Radiation Dermatitis in clinical trials. A total of 118 patients who were scheduled to receive definitive or postoperative radiotherapy or chemoradiotherapy were enrolled from the four participating cancer centers. All researchers in our group used the same model of camera under the same shooting conditions to maintain consistent photographic quality. In all, 1600 photographs were collected. Of these, 100 photographs qualified for the first round of selection and were then graded by six experts, basically in accordance with the CTCAE ver. 4.03 (JCOG ver. in Japanese). After further study, 38 photographs were selected as representing typical models for Grade 1-4 Radiation Dermatitis; the Radiation Dermatitis grading atlas was produced from these photographs. The atlas will play a major role in ensuring that the Dermatitis rating system is consistent between the institutions participating in trials. We hope that this will contribute to improving the quality of clinical trials, and also to improving the level of routine clinical practice.

Gary R. Morrow - One of the best experts on this subject based on the ideXlab platform.

  • Curcumin for Radiation Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Thirty Breast Cancer Patients
    Radiation research, 2013
    Co-Authors: Julie L. Ryan, Charles E. Heckler, Marilyn N. Ling, Alan W. Katz, Jacqueline P. Williams, Alice P. Pentland, Gary R. Morrow
    Abstract:

    Radiation Dermatitis occurs in approximately 95% of patients receiving radiotherapy (RT) for breast cancer. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the ability of curcumin to reduce Radiation Dermatitis severity in 30 breast cancer patients. Eligible patients were adult females with noninflammatory breast cancer or carcinoma in situ prescribed RT without concurrent chemotherapy. Randomized patients took 2.0 grams of curcumin or placebo orally three times per day (i.e., 6.0 grams daily) throughout their course of RT. Weekly assessments included Radiation Dermatitis Severity (RDS) score, presence of moist desquamation, redness measurement, McGill Pain Questionnaire-Short Form and Symptom Inventory questionnaire. The 30 evaluable patients were primarily white (90%) and had a mean age of 58.1 years. Standard pooled variances t test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS = 2.6 vs. 3.4; P = 0.008). Fisher's exact test revealed that fewer curcumin-treated patients had moist desquamation (28.6% vs. 87.5%; P = 0.002). No significant differences were observed between arms for demographics, compliance, Radiation skin dose, redness, pain or symptoms. In conclusion, oral curcumin, 6.0 g daily during radiotherapy, reduced the severity of Radiation Dermatitis in breast cancer patients.

  • Curcumin for Radiation Dermatitis: A randomized, double-blind, placebo-controlled clinical trial of 30 breast cancer patients.
    Journal of Clinical Oncology, 2012
    Co-Authors: Julie L. Ryan, Charles E. Heckler, Marilyn N. Ling, Jacqueline P. Williams, Alice P. Pentland, Gary R. Morrow
    Abstract:

    9027 Background: Radiation Dermatitis occurs in approximately 95% of patients receiving Radiation therapy for cancer and often leads to pain and treatment delays. There is no standard treatment with demonstrated effectiveness for the prevention of Radiation Dermatitis. We conducted a randomized, double-blind, placebo-control clinical trial to assess the efficacy of curcumin, a potent antioxidant and anti-inflammatory component of turmeric, to reduce Radiation Dermatitis in 30 breast cancer patients. Methods: Eligible patients included adult females with non-inflammatory breast cancer or carcinoma in situ prescribed Radiation therapy without concurrent chemotherapy. After randomization, patients took four 500 mg capsules of curcumin or placebo three times daily throughout their course of Radiation therapy (total daily dose = 6.0 g). Weekly assessments included Radiation Dermatitis Severity (RDS) Score, presence/absence of moist desquamation, erythema measure, and McGill Pain and Symptom Inventory (SI) ques...

  • Potential plasma biomarkers predicting Radiation Dermatitis in breast cancer patients.
    Journal of Clinical Oncology, 2010
    Co-Authors: Julie L. Ryan, Charles E. Heckler, Alice P. Pentland, Gary R. Morrow
    Abstract:

    9144 Background: Radiation Dermatitis occurs in nearly 95% of cancer patients receiving Radiation therapy. Currently, there are no useful treatments for these skin reactions. Published preclinical studies by our group showed that intragastric administration of curcumin, a potent anti-inflammatory and antioxidant, reduced Radiation skin toxicity by 50% in mice. Currently, we are conducting a randomized, double-blind, placebo-controlled study examining the use of curcumin for Radiation Dermatitis. Alterations in pro-inflammatory cytokines and chemokines may be a novel indicator for Radiation-induced skin damage. Methods: Female breast cancer patients prescribed Radiation treatment without concurrent chemotherapy were eligible. After randomization, all patients took twelve 500mg capsules of curcumin or placebo daily (i.e., 6.0g daily) during their prescribed course of Radiation treatment. The severity of Radiation Dermatitis was measured weekly using Radiation Dermatitis Score (RDS) ranging from 0 to 4 with ...