mepitel film for breast cancer

mepitel film for breast cancer

It is made out of silicone and polyurethane. Want to view more content from Cancer Therapy Advisor? Results from a phase 3 trial add to previous evidence. One patient withdrew from the standard care arm due to an unwillingness to complete follow-up. Europe PMC is an archive of life sciences journal literature. Mepitel film has not been widely adopted in North America. A Feasibility Study of Mepitel Film for the Prevention of Breast 2023 Mar 27;58:101886. doi: 10.1016/j.eclinm.2023.101886. All rights reserved. Lancet Oncol. It is FDA approved for the management of superficial wounds, such as superficial burns. PMC Secondary end points included patient- and clinician-reported outcomes. PMC 8600 Rockville Pike Radiation dermatitis (RD) is common in patients undergoing breast radiotherapy. Deaf Awareness Week: providing information and support for the Deaf community. and transmitted securely. Chow suggested that maybe a family member or other caregiver could apply the film, and he referencedan educational video from the manufacturerthat provides in-depth instructions on the correct way to apply the film for radiotherapy patients. Federal government websites often end in .gov or .mil. We want you to take advantage of everything Cancer Therapy Advisor has to offer. 2014 Jan;110(1):137-43. doi: 10.1016/j.radonc.2014.01.005. Patricia McKnight March 09, 2023 Radiation dermatitis is one of the most common side effects of radiotherapy for women with breast cancer. Patients with large breasts after lumpectomy (bra size 36 inches or cup size C) or after mastectomy were eligible. Mepitel Film in Breast Cancer and Radiation Dermatitis - ICH GCP "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. Another study by Moller et al. The objective of this study is to 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. Mepitel Film and Mepilex Lite for the prophylaxis and treatment of skin toxicities from breast radiation. Benefits of MF remained significant in patients who developed G 3 RD (n = 7, 2.8%; 95% CI, 1.1 to 5.7% v n = 17, 13.6%; 95% CI, 8.1 to 20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9 to 12.0% v n = 24, 19.2%; 95% CI, 12.7 to 27.1%, OR: 0.36). At each treatment, the breast will be evaluated by a physician for signs of infection, erythema, induration, dry or wet desquamation or frank skin breakdown, utilizing a Radiation Dermitis scale (NCI CTCAE v4.03) at each visit. Testing the Application of Mepitel Film During Radiation Therapy to Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast 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. 2019 Aug;46:87-89. doi: 10.1016/j.breast.2019.05.012. 1 Europe PMCrequires Javascript to function effectively. Unable to load your collection due to an error, Unable to load your delegates due to an error. Request PDF | On Dec 23, 2019, Karen Benstead and others published StrataXRT is as effective as Mepitel Film in reducing the incidence of moist desquamation in breast cancer patients undergoing . However, there has not been global adoption of barrier-forming films such as Mepitel, in part due to the absence of multi-centred randomised trials and the heterogeneity of study designs. Mepitel Film is marketed as a non-stick silicone wound dressing. The film is applied, sticky side to the skin, then the paper frame is removed. Recently, a phase III randomized trial by Herst et al. Results: 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. General Discussion Mepitel Film. It is FDA approved for the management of superficial wounds, such as superficial burns. Patients with large breasts or patients receiving chest wall radiation may be more likely to have worse skin reactions following radiation. One half will be randomized to Mepitel Film and the other half will be randomized to StrataXRT. 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. StrataXRT gel will be applied by the patient twice a day from day one of radiation therapy until four weeks after completion of treatment or until moist desquamation occurs, whichever comes first. Why Should I Register and Submit Results? Trained clinical research assistants (CRA) or the radiation review nurse will apply the Mepitel film for patients prior to their first radiation treatment at a designated clinic room and will check daily prior to radiation that the breast/chest wall has not been distorted by the film. Recently, a phase III randomized trial by Herst et al. 2023 Mar 17;31(4):219. doi: 10.1007/s00520-023-07671-0. 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. Continuing Medical Education (CME/CE) Courses. Epub 2020 Sep 17. The study will be conducted at approximately 5 investigative sites in the Allegheny Health Network and the accrual goal is 40 women. This is an observational cohort study of toxicity in female patients treated for early breast cancer with Adriamycin and Cyclophosphamide chemotherapy. The product is Mepitel film, from Swedish medical device company Mlnlycke Health Care Ltd. Instead, radiation dermatitis is usually treated after the fact, most often with aqueous creams. doi: 10.1111/ecc.12685. Share cases and questions with Physicians on Medscape Consult. Radiother Oncol. During course of therapy, new film may be applied as often as necessary, by trained staff if film no longer adheres to skin or comes off. Call for a Move or Boycott of Big Texas Cancer Meeting, Breast Cancer Exacts High Financial Toll Worldwide, Annual Cost of Cancer Care Reached $156 Billion, Olaparib Gains BRCA-Mutated Prostate Cancer Indication, Management of Early Breast Cancer: Lessons From a Mentor, The Connection of Weight Gain to Recurrence of Disease in Early Breast Cancer, Fast Five Quiz: Unusual Breast Cancer Presentations, Patient Simulation: A 63-Year-Old Woman With Metastatic Breast Cancer, Metastatic Breast Cancer: A Review of 3 Cases and Palliative Care, Racial Disparities in Breast Cancer Outcomes: The Role of Tumor Microenvironment. The decision whether to omit adjuvant radiation for low-risk breast cancer has historically been informed by age, tumor size, grade, receptor status . For application, the Mepitel Film has a lightweight cardboard edge to help get it property placed. Medscape Medical Newsreached out to the film manufacturer Mlnlycke Health Care. Skin reaction severity as measured by RISRAS in the NZ cohort (a) and the Chinese cohort (b). Charities Act 2005 registration #CC30021. Measured by the Radiation Induced Skin Reaction Assessment System (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). Epub 2019 May 16. It's not always possible, but if you're interested, email us at intouch@bcf.org.nz, Are we out of date? Bookshelf Journal of Medical Imaging and Radiation Sciences - ScienceDirect Using Mepitel film on the irradiated skin significantly decreases skin reaction severity by creating a moist healing environment and preventing friction between damaged skin and clothing or other body parts of the irradiated skin. Women assigned to the medial breast tissue arm, will have the area of the breast visually divided into 2 equal parts; medial and lateral. Unable to load your collection due to an error, Unable to load your delegates due to an error. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The Highmark Health Data Science Research and Development department are the statisticians for this study and will participate on the DSMB. This study aims to reduce inflammation in post-menopausal women with breast cancer through the use of asprin. Film decreased overall skin reaction severity (combined Radiation Induced Skin Reaction Assessment Scale score) by 29% and moist desquamation rates by 37% in the Chinese cohort and by 27 and 28%, respectively in the NZ cohort. Mepitel Film, an adhesive silicone skin dressing, proved more effective than standard care for preventing grade 2-3 radiation dermatitis in patients with breast cancer who had undergone mastectomy or lumpectomy before undergoing radiotherapy (RT). Mepitel film is not made with natural rubber latex (NRL). Objective: The principal investigator will share any updates, AEs and safety concerns to the Data Safety Monitoring Board (DSMB), a group of scientists, physicians, statisticians, and others that collect and analyze data during the course of a research study to monitor for adverse events and other trends that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial. Mepitel Film was applied on the first day of RT and was replaced on the last day of RT, to be worn for an additional 2 weeks after RT completion. Radiotherapy-induced skin reactions: prevention and cure. There was 1 male patient. Radiotherapy-induced skin reactions: prevention and cure. Two studies assessing Mepitel Film were critically evaluated. 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. Federal government websites often end in .gov or .mil. 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. Authors The entire study is expected to last up to 24 months. METHODS Patients were randomly assigned to receive MF or standard care (2:1 ratio). Talk with your doctor and family members or friends about deciding to join a study. After completion of radiation, patients will be called at week 1 and weeks 3-6 to assess endpoints. In the last decade, there have been no significant advances in preventing or treating radiation-induced skin toxicities. Mepitel Film - Macmillan Online Community The skin is cleaned with mild soap, rinsed with water, and dried. A Feasibility Study of Mepitel Film for the Prevention of Breast The primary endpoint was grade 2-3 radiation dermatitis during RT and within 3 months of completing RT. WhatisMepitelFilm? Between January 2020 and May 2022, 376 patients were included in the modified intention-to-treat analysis. We aimed to assess the feasibility and efficacy of Mepitel film for prevention of breast RD at a Canadian center. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. Visit. Despite the prevalence of radiation dermatitis in breast cancer patients, current practice guidelines for its treatment are limited. 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). The scale ranges from 0 to 4, with 0-being no change, 1-faint erythema or dry desquamation, 2-moderate to brisk erythema, 3-confluent moist desquamation, 4-skin necrosis or ulceration, as assessed by the physician. HHS Vulnerability Disclosure, Help Mepitel Film and Mepilex Lite for the prophylaxis and treatment of skin toxicities from breast radiation. 8600 Rockville Pike Wan BA, Chan S, Herst P, Yee C, Popovic M, Lee J, Lam H, Pon K, Aljabri S, Soliman H, Wronski M, Chow E. Breast. A Quality-Of-Life (QOL) Instrument will be completed by the patient. 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. MepitelFilmisagentle, transparent, breathable film dressingfor skinprotection. Despite the prevalence of radiation dermatitis in breast cancer patients, current practice guidelines for its treatment are limited. J Med Radiat Sci. ASCO Monthly Plenary Series 2022. redness, feeling warm or swollen), the film can be removed. Radiother Oncol. "If we can lessen the pain and discomfort, why wouldn't we as physicians? Methods: Two studies assessing Mepitel Film were critically . This website also contains material copyrighted by 3rd parties. 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. The 3-month follow-up assessment will occur at the same time as their regular clinic follow-up with their radiation oncologist. The edges stick, something like a Tegaderm. redness, feeling warm or swollen), film can be removed. Radiation-induced skin toxicity: prophylaxis or management. The proposed study is a cohort trial of women with breast cancer who are at a high risk of having pain, swelling, inflammation with skin tenderness, skin ulceration, pruritis, and scarring during radiation treatment. A Feasibility Study of Mepitel Film for the Prevention of Breast Radiation Dermatitis in a Canadian Center. 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. Read our, ClinicalTrials.gov Identifier: NCT03910595, Interventional You have reached the maximum number of saved studies (100). Disclaimer. Epub 2020 May 31. Mepitel Film Reduces Radiation Dermatitis in Breast Cancer - OBR Oncology Rates of moist desquamation and grade 2 RD were lower with Mepitel film than in studies using aqueous cream, but unlike previous trials of Mepitel film we did not achieve complete prevention of moist desquamation. Unauthorized use of these marks is strictly prohibited. MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part 1) systematic review. The film is applied to a portion of the breast or chest wall, and Herst emphasized the importance of applying the film correctly, making sure the film is not stretched during application and not overlapping other pieces of the film, while also making sure that it conforms to the breast shape. Each subject's participation will last approximately eight weeks. Then, patients will be approached by a CRA at their radiation planning appointment to review all information and obtain informed consent. Please confirm that you would like to log out of Medscape. This site needs JavaScript to work properly. In addition, there have been issues with supplies, and it has been difficult for people to get their hands on the actual product. Nov 4, 2022 Lindsay Fischer The rate of severe radiation dermatitis was reduced with the use of Mepital Film in patients with breast cancer undergoing mastectomy. government site. PDF Mepitel Film Instructions - Royal Victoria Regional Health Centre Before To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Mepitel Film is a thin, flexible, waterproof, and breathable film made of a soft silicone layer and polyurethane film. See this image and copyright information in PMC. and transmitted securely. FOIA This study is assessing the benefits of prescribed exercise in clinical populations, including people with breast cancer. Efficacy Study of Mepitel Film the Prophylaxis of Radiation-Induced There was also a significant reduction in grade 3 radiation dermatitis (2.8% vs 13.6%; OR, 0.19, P < .0002) and moist desquamation (8% vs 19.2%; OR, 0.36; P = .002). Please enable it to take advantage of the complete set of features! Accessibility However, he believes the benefits outweigh the cost. To determine the ability of Mepitel Film to reduce the severity of radiation dermatitis in patients undergoing post-mastectomy radiotherapy for breast cancer when compared to the institutional standard of care. The primary analysis will be based classification of radiation dermatitis from treated and untreated skin at each visit. National Library of Medicine Although rare, side effects of the Mepitel film included itchiness and development of acne under the film. No patients developed grade 3 RD or higher. Study Duration, Enrollment and Number of Sites Length of time on study is dependent upon the radiotherapy regimen (25 fractions or 28 fractions) and any AE probably or definitely related to study participation. sharing sensitive information, make sure youre on a federal Treatment interruptions due to severe RD may increase the risk of recurrence. Reduction in erythema will be measured in percent change, based upon physician's physical exam and assessments at baseline and at each follow up visit. Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment. 2020 Nov 16;12(22):23379-23393. doi: 10.18632/aging.103932. The film was replaced when it would curl too much around the sides, approximately every 1 or 2 weeks. doi: 10.1016/j.prro.2020.09.004. All women aged 18 years and over receiving radiation for breast cancer after having had a mastectomy are eligible for this trial. He acknowledges that it does take time that staff at most hospitals and clinics simply don't have. Of these, 11 NZ patients followed a management protocol; 11 NZ patients and 11 Chinese patients followed a prophylactic protocol. 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.

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