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

NCT06104410 | Unknown

• 1 other identifier: NU22-10-00479
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heel Spur

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of single fraction radiotherapy of heel spur

  Comparison of 2 arms in 3 months after radiotherapy.Follow-up examinations consist of personal examination,questionnaire survey.Calcaneodynia sum score (100=free of symptoms, 0=very intense symptoms) is calculated by evaluation of Pain symptoms (up to 30 points),Use of appliances (up to 15 points),Professional activities (up to 20 points),Daily/leisure activities (up to 15 points) and Gaint/limp (up to 20 points). Complete pain relief will be assumed if patients will be completely free of pain and regained full ability to walk and function well.Insufficient pain relief will be assumed,if the patient's subjective evaluation (VAS score) of improvement of pain will be less than 80% or if the temporal pattern of clinical response will be unsatisfactory (ie, response will be delayed \>3 months or there will be need for second radiotherapy course.Skin toxicity will be evaluated according Common Terminology Criteria for Adverse Events (CTCAE) v5. VAS and SF36 are described in Outcome 4.

  44 months

Secondary Outcomes (5)

• Comparison of different single fraction radiotherapy prescription

  44 months

• Comparison of the need for reirradiation till 1 year after radiotherapy between fractionated vs. single fraction radiotherapy

  44 months

• Comparison of quality of life and VAS score at 1.5, 3, 6, 9 and 12 months and Calcaneodynia sum score at 1.5, 6, 9 and 12 months between fractionated vs. single fraction radiotherapy and between different single fractions radiotherapy prescription.

  44 months

• Evaluation of individual (not sum) parts of Calcaneodynia score and individual domains of quality of life

  44 months

• Analysis of the heel spur radiotherapy techniques in Czechia

  44 months

Study Arms (2)

Arm A (standard fractionated dose): Groups A-B

ACTIVE COMPARATOR

Arm A contains of 2 groups. Group A: Total dose of 6 Gy in 4 single fractions of 1.5 Gy applied twice weekly (most commonly used regimen, considered standard arm in this trial) Group B: Total dose of 3 Gy in 2 single fractions of 1.5 Gy applied twice weekly

Radiation: Standard fractioned dose

Arm B (experimental single dose): Groups C-F

EXPERIMENTAL

Arm B contains of four groups. Group C: Total dose of 0.5 Gy in 1 single fractions of 0.5 Gy Group D: Total dose of 1 Gy in 1 single fractions of 1 Gy Group E: Total dose of 1.5 Gy in 1 single fractions of 1.5 Gy Group F: Total dose of 2 Gy in 1 single fractions of 2 Gy

Radiation: Experimental single dose

Interventions

Standard fractioned dose RADIATION

Total dose of 6 Gy in 2 or 4 single fractions of 1.5 Gy applied twice weekly.

Arm A (standard fractionated dose): Groups A-B

Experimental single dose RADIATION

Total dose of 0.5 Gy, 1Gy, 1.5 or 2Gy in 1 single fraction.

Arm B (experimental single dose): Groups C-F

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \) 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,
• \) indication to heel spur radiotherapy,
• \) 40 years or older patient, good performance status (Karnofsky index ≥ 70),
• \) willingness of the patient to provide telephone or email contact to maintain follow up.
• \) 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,
• \) corticosteroid local application during last 4 weeks prior to planned radiotherapy,
• \) rheumatic or vascular diseases, lymphatic edema of lower limb,
• \) former trauma or surgery of ipsilateral foot,
• \) any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risk for performance of radiotherapy including claustrophobia or jactation,
• \) any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements,
• \) pregnancy or breastfeeding,
• \) inability or unwillingness of subject to sign written informed consent.

Sponsors & Collaborators

• Masaryk Memorial Cancer Institute: lead

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, 656 53, Czechia

RECRUITING

Related Publications (16)

• Dufek V, Zackova H, Kotik L, Horakova I. RESULTS OF CZECH NATIONAL STUDY OF RADIATION EXPOSURE FROM RADIOTHERAPY OF NON-MALIGNANT DISEASES, IN PARTICULAR OF HEEL SPURS. Radiat Prot Dosimetry. 2019 Dec 31;186(2-3):386-390. doi: 10.1093/rpd/ncz237.

  PMID: 31840171 BACKGROUND

• Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.

  PMID: 15152061 BACKGROUND

• DeMaio M, Paine R, Mangine RE, Drez D Jr. Plantar fasciitis. Orthopedics. 1993 Oct;16(10):1153-63. doi: 10.3928/0147-7447-19931001-13. No abstract available.

  PMID: 8255812 BACKGROUND

• Heyd R, Tselis N, Ackermann H, Roddiger SJ, Zamboglou N. Radiation therapy for painful heel spurs: results of a prospective randomized study. Strahlenther Onkol. 2007 Jan;183(1):3-9. doi: 10.1007/s00066-007-1589-1.

  PMID: 17225939 BACKGROUND

• Barrett SJ, O'Malley R. Plantar fasciitis and other causes of heel pain. Am Fam Physician. 1999 Apr 15;59(8):2200-6.

  PMID: 10221305 BACKGROUND

• Kriz J, Seegenschmiedt HM, Bartels A, Micke O, Muecke R, Schaefer U, Haverkamp U, Eich HT. Updated strategies in the treatment of benign diseases-a patterns of care study of the german cooperative group on benign diseases. Adv Radiat Oncol. 2018 Feb 26;3(3):240-244. doi: 10.1016/j.adro.2018.02.008. eCollection 2018 Jul-Sep.

  PMID: 30197936 BACKGROUND

• Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.

  PMID: 12917892 BACKGROUND

• Seegenschmiedt MH, Keilholz L, Katalinic A, Stecken A, Sauer R. Heel spur: radiation therapy for refractory pain--results with three treatment concepts. Radiology. 1996 Jul;200(1):271-6. doi: 10.1148/radiology.200.1.8657925.

  PMID: 8657925 BACKGROUND

• Seegenschmiedt MH, Keilholz L, Stecken A, Katalinic A, Sauer R. [Radiotherapy of plantar heel spurs: indications, technique, clinical results at different dose concepts]. Strahlenther Onkol. 1996 Jul;172(7):376-83. German.

  PMID: 8693404 BACKGROUND

• Trott KR. Therapeutic effects of low radiation doses. Strahlenther Onkol. 1994 Jan;170(1):1-12.

  PMID: 8303572 BACKGROUND

• Bentzen SM. Radiation therapy: intensity modulated, image guided, biologically optimized and evidence based. Radiother Oncol. 2005 Dec;77(3):227-30. doi: 10.1016/j.radonc.2005.11.001. Epub 2005 Nov 21. No abstract available.

  PMID: 16300846 BACKGROUND

• Kern P, Keilholz L, Forster C, Seegenschmiedt MH, Sauer R, Herrmann M. In vitro apoptosis in peripheral blood mononuclear cells induced by low-dose radiotherapy displays a discontinuous dose-dependence. Int J Radiat Biol. 1999 Aug;75(8):995-1003. doi: 10.1080/095530099139755.

  PMID: 10465365 BACKGROUND

• Kern PM, Keilholz L, Forster C, Hallmann R, Herrmann M, Seegenschmiedt MH. Low-dose radiotherapy selectively reduces adhesion of peripheral blood mononuclear cells to endothelium in vitro. Radiother Oncol. 2000 Mar;54(3):273-82. doi: 10.1016/s0167-8140(00)00141-9.

  PMID: 10738086 BACKGROUND

• Niewald M, Seegenschmiedt MH, Micke O, Graeber S, Muecke R, Schaefer V, Scheid C, Fleckenstein J, Licht N, Ruebe C; German Cooperative Group on Radiotherapy for Benign Diseases (GCGBD) of the German Society for Radiation Oncology (DEGRO). Randomized, multicenter trial on the effect of radiation therapy on plantar fasciitis (painful heel spur) comparing a standard dose with a very low dose: mature results after 12 months' follow-up. Int J Radiat Oncol Biol Phys. 2012 Nov 15;84(4):e455-62. doi: 10.1016/j.ijrobp.2012.06.022. Epub 2012 Jul 25.

  PMID: 22836057 BACKGROUND

• Ott OJ, Jeremias C, Gaipl US, Frey B, Schmidt M, Fietkau R. Radiotherapy for benign calcaneodynia: long-term results of the Erlangen Dose Optimization (EDO) trial. Strahlenther Onkol. 2014 Jul;190(7):671-5. doi: 10.1007/s00066-014-0618-0. Epub 2014 Mar 26.

  PMID: 24668250 BACKGROUND

• Rowe CR, Sakellarides HT, Freeman PA, Sorbie C. Fractures of the Os Calcis: A Long-Term Follow-up Study of 146 Patients. JAMA. 1963;184(12):920-923. doi:10.1001/jama.1963.03700250056007

  BACKGROUND

MeSH Terms

Conditions

Heel Spur

Condition Hierarchy (Ancestors)

Exostoses; Hyperostosis; Bone Diseases; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Pavel Slampa, prof. MD

  Masaryk Memorial Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Kazda, MD

CONTACT

+420543136902; tomas.kazda@mou.cz

Marek Slavik, MD

CONTACT

+420543131187; slavik@mou.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is designed as binary outcome parallel group non-inferiority trial

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: September 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)