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Набира участници Не е приложимо NCT07546240

Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial

Не е приложима фаза (напр. обсервационно)
Заболявания: Heel Spur Syndrome

Спонсор: Maria Sklodowska-Curie National Research Institute of Oncology

Налично на: БГ
Обобщение
Heel Spur Syndrome (HSS), is a pathology characterized by chronic inflammation and degenerative changes that affect approximately 10% of adults. Although many patients respond to conservative care, about 30% experience persistent pain. Low-dose radiation therapy (LDRT) is a well-established European method with proven anti-inflammatory and immunomodulatory effects. The ORHEELS trial aims to assess whether a Polish standard dose of 6 Gy in 6 daily fractions (fx)(5 times/week) is not inferior to the treatment with total dose of 3 Gy / fx 0,5 Gy /fractionated twice weekly. The study is designed to assess the impact of intensity of treatment (daily (5 times / week) versus twice weekly fractionation) on clinical outcomes.
Описание
The aim of this study is to optimize the fractionation schedules for radiotherapy in the treatment of HSS, through a prospective randomized non-inferiority clinical trial conducted at Maria Sklodowska-Curie National Research Institute of Oncology Gliwice Branch, Poland. Purpose/Objective: * To evaluate whether the Polish standard dose (6 Gy) achieves non-inferior therapeutic effects compared to the current European Standard Dose (3 Gy). * To investigate whether daily fractionation is more effective than twice weekly fractionation in maintaining the desired immunomodulatory effect and avoiding a pro-inflammatory "rebound". * To minimize the risk of stochastic effects (secondary cancers) by halving the cumulative radiation dose.
Кой може да участва
Inclusion Criteria: * Patients aged 40 years or older. * Clinically confirmed painful Heel Spur Syndrome (plantar fasciitis) persisting for at least 3 months * No effect from previous orthopaedic, physical, or analgesic treatments. * General performance status ZUBROD 0-3. * Exclusion of other local conditions. * Patient readiness for follow-up contact. Exclusion Criteria: * Prior radiotherapy for heel spur. * Local use of corticosteroids within 4 weeks before planned radiotherapy. * Previous trauma, surgery to the foot on the same side. * Systemic diseases (eg collagen vascular disease). * Pregnancy or breastfeeding. * Lack of written informed consent
Интервенции
Standard fractioned dose
RADIATION
Reduced fractioned dose
RADIATION
Reduced fractioned dose & Intensity
RADIATION
Места на провеждане 1
Полша (1)
Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
40 Years
Здрави доброволци
Не
Начална дата
23.03.2026
Крайна дата
22.03.2030
Регистрационен номер
NCT07546240
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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