Optimizing radiotherapy schedules for heel spurs

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

This study is testing if a single low-dose radiation treatment can help people over 40 with painful heel spurs feel better, compared to the usual multiple treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 430 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Masaryk Memorial Cancer Institute (Academic / other)
• Drugs / interventions: Radiation
• Locations: 1 site (Brno)
• Trial ID: NCT06104410 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to optimize the fractionation schedules for radiotherapy in treating heel spurs, a common condition affecting many individuals. Conducted at the Masaryk Memorial Cancer Institute, the study compares the effectiveness of a single low-dose radiation treatment against the standard multi-fraction regimen. Patients over 40 years old with painful unilateral heel spurs will be enrolled and monitored for pain relief over three months. The goal is to determine if a single fraction of radiotherapy can provide comparable pain relief to the traditional approach, potentially improving treatment accessibility.

Who should consider this trial

Good fit: Ideal candidates are patients over 40 years old with a diagnosed painful unilateral heel spur for at least six months.

Not a fit: Patients with prior radiotherapy for heel spur or other local diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more efficient and accessible treatment option for patients suffering from heel spurs.

How similar studies have performed: While similar approaches have been explored, this specific optimization of fractionation schedules for heel spurs is relatively novel.

Eligibility criteria

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 interfere with adherence to study requirements,
* 7) pregnancy or breastfeeding,
* 8) inability or unwillingness of subject to sign written informed consent.

Where this trial is running

Brno

• Masaryk Memorial Cancer Institute — Brno, Czechia (Recruiting)

Study contacts

• Principal investigator: Pavel Slampa, prof. MD — Masaryk Memorial Cancer Institute
• Study coordinator: Tomas Kazda, MD

Conditions Heel Spur