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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
366
Total dose of 6 Gy (6 fractions of 1.0 Gy) administered 5 times per week
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 5 times a week.
Total dose of 3 Gy (6 fractions of 0.5 Gy) administered 2 times per week
Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland
RECRUITINGNon-inferiority of reduced fraction dose radiotherapy of heel spur
The primary endpoint will be evaluated as the difference in treatment success rates between arms A and C and between arms B and C. Success of treatment will be defined as a ≥50% reduction in pain intensity measured using the VAS scale and assessed 3 months after the end of treatment using the Pannewitz-modified pain scale relative to the baseline. Analyses for the two equivalent non-inferiority comparisons (A vs. C and B vs. C) will be performed one-sided at a significance level of α = 0.0125 (after applying the Bonferroni correction), corresponding to 97.5% two-sided confidence intervals, assuming a success rate of 65% for all three treatment regimens and an acceptable non-inferiority margin of δ=0.2, expressed as a risk difference
Time frame: 3 months after treatment
Assessment of effectiveness in pain relief
Pain relief will be evaluated using: The Visual Analogue Scale (VAS) and The modified von Pannewitz pain scale.
Time frame: 3, 6, 12 and 24 months after treatment
Assessment of functional and gait improvement
Improvement will be measured using the Rowe Score scale.
Time frame: Before and 3, 6 and 12 months after treatment
Reirradiation rate
A comparison of the number of patients requiring reirradiation defined as the proportion of patients requiring a second course of radiotherapy within 12 months of initial treatment
Time frame: Up to 12 months after treatment
Assessment of treatment safety and tolerability
The skin toxicity evaluated according to the version 5 of the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Throughout the observation period
Patients' reported Quality of Life
Evaluation of the SF-36 questionnaires
Time frame: Before and 6, 12 months after the treatment
Evaluation of inflammatory markers
Evaluation of systemic inflammation (morphology, CRP, IL-6, fibrinogen, and TNF-α)
Time frame: Before treatment and 1 month after treatment
Assessment of treatment effectiveness
The assessment will be conducted in accordance with the definitions provided, depending on the size of the irradiated area and the duration of pain symptoms (less than or more than 6 months)
Time frame: 3, 6 and 12, 24 months after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.