Клиническое исследование применения светотерапии для профилактики и лечения язв во рту у детей, больных раком (PBM)
Фотобиомодуляционная терапия для профилактики и лечения мукозитов у больных детской онкологией
The goal of this clinical trial is to learn if light therapy can prevent mouth sores in children with cancer. The main questions it aims to answer are:
Is it reasonable and acceptable to provide light therapy for children with cancer?
Does light therapy prevent mouth sores related to medical treatment?
Researchers will compare children who do not receive light therapy to children who do receive light therapy during the clinical trial to see if light therapy helps to prevent mucositis.
Participants will:
- Complete a survey.
- Have picture taken of their mouth to look for mouth sores.
- Receive light therapy every day while admitted to the hospital on the cancer unit or while admitted to an alternate unit, and continue to receive light therapy in the home setting until they reach 8 days after the start of their chemotherapy cycle.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Elissa Shulta, DNP
- Номер телефона: 414-266-5407
- Электронная почта: EShulta@childrenswi.org
Учебное резервное копирование контактов
- Имя: Peter Shaw, MD
- Номер телефона: 414-955-4086
- Электронная почта: pshaw@mcw.edu
Места учебы
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Wisconsin
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- Medical College of Wisconsin
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Младший исследователь:
- Amy Pan, PhD
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Контакт:
- Elissa Shulta, DNP
- Номер телефона: 414-266-5407
- Электронная почта: EShulta@childrenswi.org
-
Контакт:
- Peter Shaw, MD
- Номер телефона: 414-955-4086
- Электронная почта: pshaw@mcw.edu
-
Младший исследователь:
- Peter Shaw, MD
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Младший исследователь:
- Valerie Lohse, MSN
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Главный следователь:
- Elissa Shulta, DNP
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Младший исследователь:
- Sarah Joost, MSN
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Младший исследователь:
- Meredith Beversdorf, BSN
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Младший исследователь:
- Amberley Kemic, BSN
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Младший исследователь:
- Ashley Hain, BSN
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Current and new diagnosis patients consented upon admission if deemed eligible
- Ages 0-30
- Admitted to CW oncology/BMT inpatient unit, PICU, or West 5
- Chemotherapy regimen: Methotrexate ≥5 g/m2 (or ≥1 g/m2 if Trisomy 21) OR Anthracycline ≥60 mg/m2
- Able to speak and understand English or Spanish
Exclusion Criteria:
- Patients admitted on BMT service
- Patients currently experiencing mucositis with a CTCAE grade 4 oral mucositis or higher
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Без вмешательства: Control Arm
Prospective data review of patients who did not receive light therapy |
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Активный компаратор: Prevention Arm
Prospective data review of patients who did receive light therapy |
Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients <7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes. Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
Другие имена:
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Активный компаратор: Exploratory Arm
Prospective review of patients with Trisomy 21 who did receive light therapy |
Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients <7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes. Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Evaluate the feasibility of using PBM in pediatric oncology patients.
Временное ограничение: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
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Feasibility of PBM will be assessed by the RN completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the ease of delivery of PBM therapy. A score of ≥3 indicates that the PBM therapy was feasible. |
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
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Evaluate the acceptability of using PBM in pediatric oncology patients.
Временное ограничение: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
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Acceptability of PBM will be assessed by the patient/caregiver completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the patient's tolerance of the treatment. A score of ≥3 indicates acceptability of PBM therapy. |
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Evaluate the effectiveness of using PBM in reducing the incidence and severity of mucositis in pediatric oncology patients receiving chemotherapy.
Временное ограничение: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
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This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record based on the number of unique patients with the value of "mucositis/stomatitis" in the oral mucosa flowsheet row. Additionally, mucositis onset, severity, and grade will be measured using the CTCAE grading scale and the ChIMES patient/caregiver survey |
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
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Evaluate the effectiveness of using PBM based on MBI CLABSI rate.
Временное ограничение: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
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This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the rate of MBI CLABSIs per 1,000 line days. |
From date of enrollment until date of last PBM treatment, assessed up to 2 years.
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Antunes HS, Herchenhorn D, Small IA, Araujo CMM, Viegas CMP, de Assis Ramos G, Dias FL, Ferreira CG. Long-term survival of a randomized phase III trial of head and neck cancer patients receiving concurrent chemoradiation therapy with or without low-level laser therapy (LLLT) to prevent oral mucositis. Oral Oncol. 2017 Aug;71:11-15. doi: 10.1016/j.oraloncology.2017.05.018. Epub 2017 Jun 3.
- Zadik Y, Arany PR, Fregnani ER, Bossi P, Antunes HS, Bensadoun RJ, Gueiros LA, Majorana A, Nair RG, Ranna V, Tissing WJE, Vaddi A, Lubart R, Migliorati CA, Lalla RV, Cheng KKF, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer. 2019 Oct;27(10):3969-3983. doi: 10.1007/s00520-019-04890-2. Epub 2019 Jul 8.
- Treister NS, London WB, Guo D, Malsch M, Verrill K, Brewer J, Margossian S, Duncan C. A Feasibility Study Evaluating Extraoral Photobiomodulation Therapy for Prevention of Mucositis in Pediatric Hematopoietic Cell Transplantation. Photomed Laser Surg. 2016 Apr;34(4):178-84. doi: 10.1089/pho.2015.4021. Epub 2016 Mar 16.
- Miranda-Silva W, da Fonseca FP, Gomes AA, Mafra ABB, Rocha V, Fregnani ER. Oral mucositis in paediatric cancer patients undergoing allogeneic hematopoietic stem cell transplantation preventively treated with professional dental care and photobiomodulation: Incidence and risk factors. Int J Paediatr Dent. 2022 Mar;32(2):251-263. doi: 10.1111/ipd.12850. Epub 2021 Jul 20.
- Lima AG, Antequera R, Peres MP, Snitcosky IM, Federico MH, Villar RC. Efficacy of low-level laser therapy and aluminum hydroxide in patients with chemotherapy and radiotherapy-induced oral mucositis. Braz Dent J. 2010;21(3):186-92. doi: 10.1590/s0103-64402010000300002.
- Heimlich FV, de Arruda JAA, Pereira NM, Faria LDS, Abreu LG, Ferreira MVL, Kakehasi FM, Travassos DV, Silva TA, Mesquita RA. Proposal of a prophylactic photobiomodulation protocol for chemotherapy-induced oral and oropharyngeal mucositis: a randomized clinical trial. Lasers Med Sci. 2023 Oct 27;38(1):245. doi: 10.1007/s10103-023-03916-w.
- Chaves ME, Araujo AR, Piancastelli AC, Pinotti M. Effects of low-power light therapy on wound healing: LASER x LED. An Bras Dermatol. 2014 Jul-Aug;89(4):616-23. doi: 10.1590/abd1806-4841.20142519.
- Cheng KK, Lee V, Li CH, Yuen HL, Epstein JB. Oral mucositis in pediatric and adolescent patients undergoing chemotherapy: the impact of symptoms on quality of life. Support Care Cancer. 2012 Oct;20(10):2335-42. doi: 10.1007/s00520-011-1343-1. Epub 2011 Dec 14.
- Pritchard M, Ogg SW, Bosi J, Mandrell BN. Utilization of Photobiomodulation for the Prevention and Treatment of Oral Mucositis. J Pediatr Hematol Oncol Nurs. 2024 Mar-Apr;41(2):107-113. doi: 10.1177/27527530231214525. Epub 2024 Feb 20.
- Hafner D, Hrast P, Tomazevic T, Jazbec J, Kavcic M. Photobiomodulation for Chemotherapy-Induced Oral Mucositis in Pediatric Patients. Biomolecules. 2023 Feb 23;13(3):418. doi: 10.3390/biom13030418.
- de Farias Gabriel A, Silveira FM, Curra M, Schuch LF, Wagner VP, Martins MAT, da Silveira Matte U, Siebert M, Botton MR, Brunetto AT, Gregianin LJ, Martins MD. Risk factors associated with the development of oral mucositis in pediatric oncology patients: Systematic review and meta-analysis. Oral Dis. 2022 May;28(4):1068-1084. doi: 10.1111/odi.13863. Epub 2021 Apr 9.
- Berger K, Schopohl D, Bollig A, Strobach D, Rieger C, Rublee D, Ostermann H. Burden of Oral Mucositis: A Systematic Review and Implications for Future Research. Oncol Res Treat. 2018;41(6):399-405. doi: 10.1159/000487085. Epub 2018 May 3.
- Antunes HS, de Azevedo AM, da Silva Bouzas LF, Adao CA, Pinheiro CT, Mayhe R, Pinheiro LH, Azevedo R, D'Aiuto de Matos V, Rodrigues PC, Small IA, Zangaro RA, Ferreira CG. Low-power laser in the prevention of induced oral mucositis in bone marrow transplantation patients: a randomized trial. Blood. 2007 Mar 1;109(5):2250-5. doi: 10.1182/blood-2006-07-035022. Epub 2006 Oct 19.
- Alsheyyab F, Al-Momani D, Kasht R, Kamal A, Abusalem D, Al-Qasem W. Impact of severe oral mucositis in pediatric cancer patients on resource utilization and cancer treatment plans. Int J Clin Pharm. 2021 Oct;43(5):1322-1326. doi: 10.1007/s11096-021-01253-y. Epub 2021 Mar 3.
- Jacobs S, Baggott C, Agarwal R, Hesser T, Schechter T, Judd P, Tomlinson D, Beyene J, Sung L. Validation of the Children's International Mucositis Evaluation Scale (ChIMES) in paediatric cancer and SCT. Br J Cancer. 2013 Nov 12;109(10):2515-22. doi: 10.1038/bjc.2013.618. Epub 2013 Oct 15.
- Treister NS, Nieder M, Baggott C, Olson E, Lo T, Jin X, Gao Y, Chen L, Dang H, Sung L. Validation of healthcare professional proxy-reported children's International Mucositis Evaluation Scale. Oral Dis. 2023 Mar;29(2):747-754. doi: 10.1111/odi.13918. Epub 2021 May 26.
- Rabin KR, Smith J, Kozinetz CA. Myelosuppression and infectious complications in children with Down syndrome and acute lymphoblastic leukemia. Pediatr Blood Cancer. 2012 Apr;58(4):633-5. doi: 10.1002/pbc.23371. Epub 2011 Nov 21.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- PRO00051962
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .