Impact of Total Dose and Fractionation on Clinical Outcomes of Low-Dose Radiotherapy for Heel Spur Syndrome: Optimal Radiotherapy - Heel Spur Syndrome (ORHEELS) Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Non-inferiority of reduced fraction dose radiotherapy of heel spur
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Exclusion of other local conditions.
- •Patient readiness for follow-up contact.
排除标准
- •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
研究组 & 干预措施
Arm A
Polish Standard Dose
干预措施: Standard fractioned dose (Radiation)
Arm B
Arm B (Reduced Dose)
干预措施: Reduced fractioned dose (Radiation)
Arm C
(Reduced Dose & Intensity)
干预措施: Reduced fractioned dose & Intensity (Radiation)
结局指标
主要结局
Non-inferiority of reduced fraction dose radiotherapy of heel spur
时间窗: 3 months after treatment
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
次要结局
- Assessment of effectiveness in pain relief(3, 6, 12 and 24 months after treatment)
- Assessment of functional and gait improvement(Before and 3, 6 and 12 months after treatment)
- Reirradiation rate(Up to 12 months after treatment)
- Assessment of treatment safety and tolerability(Throughout the observation period)
- Patients' reported Quality of Life(Before and 6, 12 months after the treatment)
- Evaluation of inflammatory markers(Before treatment and 1 month after treatment)
- Assessment of treatment effectiveness(3, 6 and 12, 24 months after treatment)