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Optimization of Fractionation Schedules of Heel Spur Radiotherapy Prospective Randomized Open-label Trial

Czechia430 participantsStarted 2022-09-01

Plain-language summary

About 26 000 patients are treated per year with radiotherapy for non-malignant diseases in the Czech Republic, majority of them with heel spur syndrome which prevalence ranges from 8-10% in the general population. Heel spur represents important socioeconomic as well as health care issue. Radiotherapy by orthovoltage X-ray belongs to standard conservative treatment methods with proven antiinflammatory effect. Nevertheless, with increasing incidence of cancer, it may be assumed that availability of radiotherapy service for heel spur patients will be further limited including limitations related to potential pandemic or other emergency situation. This represents upcoming unmet clinical need, where alternative approaches with dramatically abbreviated fractionation schedules are needed in order to keep availability as well as effectivity of heel spur (and other non-malignant disorders) radiotherapy. The aim to presented single institutional prospective randomized open-lable clinical trial is to evaluate low dose radiotherapy delivered in single fraction manner in the treatment of heel spur syndrome. The project aims to design a randomized trial that compared fractionated and single fraction radiotherapy (non-inferiority). Patients will be randomized into 6 groups according to the total dose, total of 966 patients will be enrolled. The primary objective is to compare Calcaneodynia sum score at 3 months after radiotherapy between fractionated vs. single fraction radiotherapy.

Who can participate

Age range40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

All patients referred to medical attention for non-malignant radiotherapy at the Department of Radiation oncology, Masaryk Memorial Cancer Institute (MMCI), will be screened for eligibility, and if all inclusion/exclusion criteria are met, they will be invited to participate in the present study. Inclusion Criteria: * 1\) Patients aged over 40 years who have been diagnosed clinically and radiologically to be suffering from a painful unilateral plantar heel spur for at least six months, * 2\) indication to heel spur radiotherapy, * 3\) 40 years or older patient, good performance status (Karnofsky index ≥ 70), * 4\) exclusion of other local diseases by the orthopaedic surgeon, * 5\) willingness of the patient to provide telephone or email contact to maintain follow up. Exclusion Criteria: * 1\) Prior radiotherapy of heel spur (even if prior radiotherapy was performed on the contralateral heel spur because of possible bias given patient's expectations and experiences related to previous radiotherapy, * 2\) corticosteroid local application during last 4 weeks prior to planned radiotherapy, * 3\) rheumatic or vascular diseases, lymphatic edema of lower limb, * 4\) former trauma or surgery of ipsilateral foot, * 5\) any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risk for performance of radiotherapy including claustrophobia or jactation, * 6\) any other factors that, in the opinion of the site investigators, would inter…

What they're measuring

Non-inferiority of single fraction radiotherapy of heel spur

Timeframe: 44 months

Trial details

NCT IDNCT06104410

SponsorMasaryk Memorial Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

Contact for this trial

Tomas Kazda, MD

+420543136902 tomas.kazda@mou.cz