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Recruiting Not applicable NCT07546240

Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial

No applicable phase (e.g. observational)
Conditions: Heel Spur Syndrome

Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
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
Interventions
Standard fractioned dose
RADIATION
Reduced fractioned dose
RADIATION
Reduced fractioned dose & Intensity
RADIATION
Locations 1
Poland (1)
Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Healthy volunteers
No
Start date
23.03.2026
Completion date
22.03.2030
Registry ID
NCT07546240
Source
clinicaltrials.gov
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