Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial (ORHEELS)

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Enrolling

Conditions: Heel Spur Syndrome

Treatments: Radiation: Standard fractioned dose; Radiation: Reduced fractioned dose & Intensity; Radiation: Reduced fractioned dose

Study type: Interventional

Funder types: Other

Identifiers

NCT07546240

ORHEELS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 366 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 3 patient groups

Arm A

Experimental group

Description:

Polish Standard Dose

Treatment:

Radiation: Standard fractioned dose

Arm B

Experimental group

Description:

Arm B (Reduced Dose)

Treatment:

Radiation: Reduced fractioned dose

Arm C

Other group

Description:

(Reduced Dose \& Intensity)

Treatment:

Radiation: Reduced fractioned dose & Intensity