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Recent studies that have investigated the use of Mepitel film in patients with head and neck cancer and breast cancer respectively.27,28 Neither study reported statistically significant improvements in reaction when using the Mepitel film. The patients were randomly assigned 2:1 to receive Mepitel Film (n=251) or standard skin care (n=125) during RT. Throughout the study, information will be collected to analyze at the end of the research study to determine if the Mepitel Film helps prevent skin breakdown. The questionnaire asks subjects to rate symptoms on a scale from 1 to 4 (1 being excellent or no side effect to 4 being poor or worst side effect). 8600 Rockville Pike Mepitel film is not made with natural rubber latex (NRL). Subjects will also be asked to choose the word (with definition) that best describes how their breast looks (excellent, good, poor or fair). Study Description Go to Brief Summary: The purpose of this research is to evaluate the use of Mepitel Film in preventing radiation epidermitis in patients receiving radiation treatment for breast cancer. Radiation-induced skin toxicity: prophylaxis or management. MepitelFilmisagentle, transparent, breathable film dressingfor skinprotection. Two randomized trials of Mepitel film demonstrated efficacy in preventing severe RD in breast cancer, but this product has not been widely adopted in North America. official website and that any information you provide is encrypted Unauthorized use of these marks is strictly prohibited. Patients who underwent a lumpectomy had a bra size of at least 36 inches and/or a cup size of C or higher. Breast Cancer Radiation Dermatitis Intervention / Treatment Device: Mepitel Film Detailed Description Breast cancer patients undergoing adjuvant radiotherapy commonly experience radiation-induced skin toxicities which adversely impact patients' quality of life. Based on these results, researchers recommend the use of Mepitel Film for preventing moderate to severe radiation dermatitis in patients at high risk. Two randomized trials of Mepitel film demonstrated efficacy in preventing severe RD in breast cancer, but this product has not been widely adopted in North America. 2018 Jun 1;101(2):325-333. doi: 10.1016/j.ijrobp.2018.02.006. Copyright 2019 Elsevier Ltd. All rights reserved. We want you to take advantage of everything Cancer Therapy Advisor has to offer. 2023 Mar 17;31(4):219. doi: 10.1007/s00520-023-07671-0. Aging (Albany NY). We aimed to conduct a confirmatory randomized controlled trial in patients at risk of RD. 2023 Mar 17;31(4):219. doi: 10.1007/s00520-023-07671-0. An area of the neck receiving a homogenous radiation dose of > 35 Gy was divided into two equal halves; one half was randomized to Film and the other to either Sorbolene cream (NZ) or Biafine cream (China). Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast A Feasibility Study of Mepitel Film for the Prevention of Breast The study will be conducted at approximately 5 investigative sites in the Allegheny Health Network and the accrual goal is 40 women. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Would you like email updates of new search results? 2023 Mar 27;58:101886. doi: 10.1016/j.eclinm.2023.101886. Mexican radiationdermatitis management consensus. Before A Retrospective Chart Review on the Prophylactic Use of Mepitel Film for Breast Cancer Patients undergoing Chest Wall Irradiation: A Single-institution Experience Fatima Oshin, LouAnn McBrayne, Melissa Bratt, Michelle Lucier, . Epub 2014 Jan 30. This study is assessing the benefits of prescribed exercise in clinical populations, including people with breast cancer. Radiation-induced skin injury: pathogenesis, treatment, and management. Federal government websites often end in .gov or .mil. MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part 1) systematic review. Register now at no charge to access unlimited clinical news, full-length features, case studies, conference coverage, and more. Patricia McKnight March 09, 2023 Radiation dermatitis is one of the most common side effects of radiotherapy for women with breast cancer. Want to access a trial that's not in your area? It should be used for women who are at high risk for developing radiation dermatitis, said Edward Chow, MBBS, PhD, of the Department of Radiation Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada, who was the senior author of the phase 3 study published recently in the Journal of Clinical Oncology. Bethesda, MD 20894, Web Policies Conclusion: Replacement of the film may be done as often as necessary. Bethesda, MD 20894, Web Policies The breast will be photographed and assessed at the beginning of therapy and at weeks 3, 5 and 6 the 3 (which will occur if clinically indicated) and one week following the completion of therapy. Before The breast will be photographed and assessed at the beginning of therapy and at weeks 3, 5 and 6 the 3 (which will occur if clinically indicated) and one week following the completion of therapy. See our registration details on the Charities Commission website. A representative with the company, Allyson Bower-Willner, could not comment on the distribution of Mepitel film in the United States or if the company plans to increase the amount of product shipped. Compared with patients who received standard care, patients treated with Mepitel Film reported significantly less tenderness, discomfort, or pain (P =.001); burning sensation (P =.004); blistering or peeling (P =.009); erythema (P =.001); pigmentation changes (P <.0001); and edema (P =.03). Epub 2020 Nov 16. Behroozian T, Bonomo P, Patel P, Kanee L, Finkelstein S, van den Hurk C, Chow E, Wolf JR; Multinational Association of Supportive Care in Cancer (MASCC) Oncodermatology Study Group Radiation Dermatitis Guidelines Working Group. The skin is cleaned with mild soap, rinsed with water, and dried. Mepitel Film reduced acute radiation-induced skin reactions in our head and neck cancer patients, particularly in patients without heavy stubble. Lancet Oncol. Europe PMC Breast cancer patients report reduced sensitivity and pain using a barrier film during radiotherapy - A Danish intra-patient randomized multicentre study. Objective: Mepitel Film significantly decreases acute radiation-induced skin reactions in breast cancer patients. A randomized trial (RAREST-01) comparing Mepitel Film and standard This is an observational cohort study of toxicity in female patients treated for early breast cancer with Adriamycin and Cyclophosphamide chemotherapy. Did anybody use Mepitel film during or after radiotherapy? Both reported that Mepitel Film decreased radiation dermatitis; moreover, patient-reported outcomes significantly favoured Mepitel Film. Mepitel film will be applied by the radiation therapist once a week from day one of radiation therapy until four weeks after completion of treatment or until moist desquamation occurs, whichever comes first. Conclusions: The film will be removed two weeks post radiation treatment. HHS Vulnerability Disclosure, Help October 18, 2022. and transmitted securely. 21 Another promising approach for prevention of breast RD is the Mepitel film. Results: Keywords provided by Dr. Edward Chow, Sunnybrook Health Sciences Centre: Why Should I Register and Submit Results? Tenorio C, de la Mata D, Leyva JAF, Poitevin-Chacon A, Queijeiro MV, Gutirrez GR, Nogueda JC, Cons LCD, Hernandez YB, Snchez DR, Cruz AAS, Guardado GN, Tomasena MI, Ortiz S, Del Bosque MAS, Garzn LAC, Puch AES, Retif RP, Arceo PRL, Lpez LHB, Baldi CMT. An official website of the United States government. In addition, there have been issues with supplies, and it has been difficult for people to get their hands on the actual product. Mepitel Film for the prevention of acute radiation dermatitis in breast cancer: A randomized multi-centre open-label phase 3 trial. Of these, 11 NZ patients followed a management protocol; 11 NZ patients and 11 Chinese patients followed a prophylactic protocol. A Feasibility Study of Mepitel Film for the Prevention of Breast 2019 Aug;46:87-89. doi: 10.1016/j.breast.2019.05.012. There were 8 patients who switched from Mepitel Film to standard care 2 due to an allergic rash, 1 due to excessive pruritus, and 5 for other reasons. Individual items on the Radiation-Induced Skin Reaction Assessment Scale also favored the MF for both patient- and clinician-reported outcomes. All women aged 18 years and over receiving radiation for breast cancer after having had a mastectomy are eligible for this trial. Robijns J, Aquilano M, Banerjee S, Caini S, Wolf JR, van den Hurk C, Beveridge M, Lam H, Bonomo P, Chow E, Behroozian T. Support Care Cancer. sharing sensitive information, make sure youre on a federal The Highmark Health Data Science Research and Development department are the statisticians for this study and will participate on the DSMB. FOIA Topical antibiotics were required in 23.1% of patients in the Mepitel Film arm and 43.2% of those in the standard care arm (P <.0001). This film will be given to patients in one of three patient populations: Choosing to participate in a study is an important personal decision. Despite the prevalence of radiation dermatitis in breast cancer patients, current practice guidelines for its treatment are limited. Epub 2019 May 16. The primary endpoint was grade 2-3 radiation dermatitis during RT and within 3 months of completing RT. Mepitel Film and Mepilex Lite for the prophylaxis and treatment of skin toxicities from breast radiation. Mepitel film was effective and well-tolerated by this cohort of Canadian breast cancer patients, completely preventing grade 3 RD and reducing rates of grade 2 RD and MD. Further research is needed to confirm the efficacy of Mepitel film versus standard prophylaxis for RD and identify the patients who will benefit the most from the film. Mepitel Film and Mepilex Lite for the prophylaxis and treatment of skin Close more info about Mepitel Film Reduces Radiation Dermatitis in Breast Cancer Patients, Mepitel Film for the prevention of acute radiation dermatitis in breast cancer: A randomized multi-centre open-label phase 3 trial, Enlarging Breast Mass in 69-Year-Old Woman With History of Cysts. Stratification factors included surgery type, dose fractionation, and administration of boost/bolus. Measured by the RISRAS; researcher subscales for erythema and dry desquamation rated from 0 (best) to 4 (worst); researcher subscale for moist desquamation rated from 0 (best) to 6 (worst); researcher subscale for necrosis rated from 0 (best) to 10 (worst); patient subscales for tenderness/discomfort/pain, itchiness, burning sensation, and interference with daily activities rated from 0 (best) to 3 (worst). Your use of this website constitutes acceptance of Haymarket Medias Privacy Policy and Terms & Conditions. The Mepitel Film has been purchased for this study by the Allegheny General Hospital (AGH) Auxiliary and each box of Film received will be then labeled for investigational use only. The infra-mammary crease will be part of both the medial and lateral breast segments. Secondary outcomes included moist desquamation, patient- and clinician-reported symptoms of skin toxicity, and cosmetic outcomes. Radiother Oncol. Radiotherapy-induced skin reactions: prevention and cure. Mepitel Film is marketed as a non-stick silicone wound dressing. Barrier Films and Dressings for the Prevention of Acute Radiation Dermatitis: A Systematic Review and Meta-Analysis. Mepitel Film Reduces Radiation Dermatitis in Breast Cancer - OBR Oncology (n=78) in New Zealand showed that the prophylactic use of Mepitel Film reduced skin reaction severity by 92% compared to skin treated only with aqueous cream. and transmitted securely. 2019 Aug;46:87-89. doi: 10.1016/j.breast.2019.05.012. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149522, We're building a modernized ClinicalTrials.gov! Mepitel Film in Breast Cancer and Radiation Dermatitis - ICH GCP Visits related to an adverse event (AE) will continue until the AE is resolved, which may extend participation time. -Medscape-Mar09,2023. Aging (Albany NY). Authors The Film will be placed by the physician or his/her designee to cover approximately one-half of the breast divided in the cephalo-caudal plane. National Library of Medicine Epub 2018 Feb 14. New; Breast cancer forum requires membership for participation - click to join. PMC Unauthorized use of these marks is strictly prohibited. Subscribe for updates & stay in the loop with new studies. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Medscape Medical Newsreached out to the film manufacturer Mlnlycke Health Care. If there are signs of infection (e.g. Evaluation of Mepitel Film in Preventing Epidermitis in Patients 2019 Dec 16;11(12):2112. doi: 10.3390/polym11122112. Information provided by (Responsible Party): Dr. Edward Chow, Sunnybrook Health Sciences Centre. 2021 Jan-Feb;11(1):e36-e45. Unauthorized use of these marks is strictly prohibited. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. redness, feeling warm or swollen), film can be removed. The 3-month follow-up assessment will occur at the same time as their regular clinic follow-up with their radiation oncologist. Yee C, Lam E, Gallant F, Karam I, Czarnota G, Soliman H, Wong G, Drost L, Vesprini D, Rakovitch E, Wronski M, Leung E, Szumacher E, Carothers K, Pon K, Gonzales G, Easton L, Lewis D, Zhang L, Chow E. Pract Radiat Oncol. Behroozian T, Goldshtein D, Ryan Wolf J, van den Hurk C, Finkelstein S, Lam H, Patel P, Kanee L, Lee SF, Chan AW, Wong HCY, Caini S, Mahal S, Kennedy S, Chow E, Bonomo P; Multinational Association of Supportive Care in Cancer (MASCC) Oncodermatology Study Group Radiation Dermatitis Guidelines Working Group. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. The .gov means its official. Advances in knowledge: This is the first study to confirm the feasibility of using Mepitel Film in head and neck cancer patients. official website and that any information you provide is encrypted 2014 Jan;110(1):137-43. doi: 10.1016/j.radonc.2014.01.005. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. The incidence of grade 2-3 radiation dermatitis was significantly lower in the Mepitel Film arm than in the standard care arm 15.54% and 45.60%, respectively (odds ratio [OR], 0.20; 95% CI, 0.12-0.34; P <.0001). Despite the prevalence of radiation dermatitis in breast cancer patients, current practice guidelines for its treatment are limited. Visit. Clinicians reported similar improvements. "We have been using the film at Mayo for a number of years," Corbin said, but we have "have found that it is challenging to get supplies. The film is applied, sticky side to skin and paper frame is removed. Share cases and questions with Physicians on Medscape Consult. Skin dose was measured by thermoluminescent dosimeters or gafchromic film. Mepitel Film can reduce the risk of radiation dermatitis in patients with breast cancer, according to research presented as part of the 2022 ASCO Monthly Plenary Series for October. If you have updated or new information about a trial, wed be grateful if youd share it with us email your update to intouch@bcf.org.nz. Results from a phase 3 trial add to previous evidence from smaller trials that show that a silicone-based film can protect skin from this side effect. Clipboard, Search History, and several other advanced features are temporarily unavailable. Behroozian T, Goldshtein D, Ryan Wolf J, van den Hurk C, Finkelstein S, Lam H, Patel P, Kanee L, Lee SF, Chan AW, Wong HCY, Caini S, Mahal S, Kennedy S, Chow E, Bonomo P; Multinational Association of Supportive Care in Cancer (MASCC) Oncodermatology Study Group Radiation Dermatitis Guidelines Working Group. Methods: BIR Publications As a part of this research study, the Mepitel Film will be placed prior to participant's first radiation treatment, and will be removed one week following the end of treatment. Please remove one or more studies before adding more. ClinicalTrials.gov Identifier: NCT04149522, Interventional An official website of the United States government. One of the negative aspects of Mepitel film is that it needs to be applied very carefully by a radiation therapist or an oncology nurse once a week or more often in some patients, which takes up valuable staff resources. This study aims to reduce inflammation in post-menopausal women with breast cancer through the use of asprin. ", "While we have generally been able to have some supply established through our store here, we know that is not typical and it is difficult for patients to access," she said. One half will be randomized to Mepitel Film and the other half will be randomized to StrataXRT. View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. HHS Vulnerability Disclosure, Help Robijns J, Aquilano M, Banerjee S, Caini S, Wolf JR, van den Hurk C, Beveridge M, Lam H, Bonomo P, Chow E, Behroozian T. Support Care Cancer. Fernndez-Castro M, Martn-Gil B, Pea-Garca I, Lpez-Vallecillo M, Garca-Puig ME. Clipboard, Search History, and several other advanced features are temporarily unavailable. doi: 10.12968/bjon.2014.23.Sup16.S24. Cite this: Mepitel Film for Radiation Dermatitis: It Works, so Why Isn't It Used? Please enable it to take advantage of the complete set of features! The in-field ipsilateral axilla will be included with the lateral breast segment to the extent necessary for coverage of the breast or chest wall only. Clinical Phase II trial to determine if Mepitel Film is a viable prophylactic option for high-risk women undergoing radiotherapy for breast cancer to reduce side effects of radiation on the skin. ", Radiation dermatitis from radiotherapy following a mastectomy, Chow's open-label, multicenter trial was conducted in 376 women with large breasts (bra cup size C or larger) who were undergoing radiotherapy after lumpectomy or mastectomy. Modern Dressings in Prevention and Therapy of Acute and Chronic Radiation Dermatitis-A Literature Review. Recently, a phase III randomized trial by Herst et al. Epub 2017 Apr 18. Why Should I Register and Submit Results? The film will remain in place until one week following the last day of radiotherapy, where it will be removed by the physician or clinically trained staff. official website and that any information you provide is encrypted The film will remain in place until one week following the last day of radiotherapy, where it will be removed by the physician or trained staff. The film is available "to a limited set of customers," she said. Br J Nurs. In Chow's study, the average time spent applying the film on lumpectomy patients was 55 minutes and was slightly shorter at 45 minutes for mastectomy patients. Mayo Clinic principal investigator Kimberly Corbin, MD, could not go into great detail about the ongoing trial, but she said it has been difficult to get the product. In the study, 30 patients will have the film applied on their breast for the duration of radiation treatment and their skin reactions will be assessed throughout the treatment and after the treatment. Studies have shown that Mepitel Film can significantly reducetheskin reaction that mayhappen withradiation treatment. An official website of the United States government. We aimed to discuss the quality of evidence for the barrier-forming Mepitel Film for prophylaxis of radiation dermatitis, and argue for further investigation into evidence-based management of skin toxicities.Two studies assessing Mepitel Film were critically . HowisMepitelFilmapplied? You have reached the maximum number of saved studies (100). At each treatment, the breast will be evaluated for signs of infection, erythema, induration, dry or wet desquamation or frank skin breakdown. doi: 10.1016/j.prro.2020.09.004. Results from a phase 3 trial add to previous evidence. Statistical analysis will be completed by Highmark Health Data Science R&D. The cost of Mepitel film may also be a deterrent. Please enable it to take advantage of the complete set of features! active rash, pre-existing dermatitis) or known allergy to adhesives or tapes; or known allergy to the Mepitel Film. eCollection 2022. Patients will complete evaluations once a week at their regular review clinic visit and will be assessed by an HCP or CRA. eCollection 2023 Apr. Radiation treatment will be delivered as prescribed by the treating radiation oncologist and may include a variety of techniques and beam modifiers. A QOL questionnaire will be completed by each patient prior to first radiation treatment and at weeks 3, 5 and 6 (which will occur if clinically indicated) of radiotherapy, and 1 week following the completion of irradiation. Secondary end points included patient- and clinician-reported outcomes. Out of a total of 36 head and neck cancer patients from New Zealand (NZ) (n = 24) and China (n = 12) recruited between June 2015 and December 2016, 33 patients complied with protocol. official website and that any information you provide is encrypted An HCP will also conduct an assessment. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Clipboard, Search History, and several other advanced features are temporarily unavailable. Time to healing skin treated with and without the film will be measured in days, based upon physician's physical exam and assessments at baseline and at each follow up visit. Federal government websites often end in .gov or .mil. Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. "[Radiation dermatitis] is usually associated with pain and discomfort and can lead to more serious issues like infection or delayed wound healing, and unfortunately, there aren't effective treatments for it once it's developed, so preventing it is our most effective strategy," Speers said. Please enable it to take advantage of the complete set of features! Mepitel Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. Prior to standard of care radiation treatments, women will have the area of the breast divided into two, approximately equal parts; medial and lateral. Read our, ClinicalTrials.gov Identifier: NCT03910595, Interventional To view unlimited content, log in or register for free. This allows for repair of the fragile skin rather than exacerbating the damage. Epub 2020 May 31. Mepitel Film has not been widely adopted in North American clinical practice. Careers. Mepitel Film Reduces Radiation Dermatitis in Breast Cancer Patients Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Evaluate the efficacy of use of Mepitel Film in the prevention of grade II or higher radiation epidermitis in high-risk patients undergoing radiotherapy for breast cancer [TimeFrame:7 weeks from initiation], Quality of Life (QOL) responses [TimeFrame:7 weeks from initiation], Time until the onset of erythema [TimeFrame:7 weeks from initiation], Time to healing skin treated with and without the film [TimeFrame:7 weeks from initiation], Reduction in erythema [TimeFrame:7 weeks from initiation], Reduction in moist desquamation [TimeFrame:7 weeks from initiation], Biopsy-proven diagnosis of breast cancer (Stage 0 - II) with the breast tumor completely removed, Whole breast or chest wall irradiation with or without ipsilateral axillary radiotherapy, Women of child-bearing potential must use an effective form of birth control, Women with evident skin irritation or skin infection (i.e. Mepitel Film is superior to Biafine cream in managing acute radiation-induced skin reactions in head and neck cancer patients: a randomised intra-patient controlled clinical trial.

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