An interventional study of Standard fractioned dose and Experimental single dose in Heel Spur, sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Treatment
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.
Purpose/Objective The aim of this study is to optimize the fractionation schedules for radiotherapy in the treatment of heel spurs (HSS, plantar fasciitis) through a prospective randomized open-label trial conducted at Department of Radiation Oncology at Masaryk Memorial Cancer Institute Brno (MMCI). Low-dose external beam radiotherapy (LD-EBRT), known for its anti-inflammatory effect, offers effective pain relief for HSS patients. Currently, the standard LD-EBRT regimen consists of six fractions of 1 Gray (Gy) administered twice weekly, resulting in a total dose of 6 Gy. This study posits the hypothesis that very low total doses of orthovoltage radiotherapy, delivered in a single fraction, may provide pain relief comparable to that achieved with higher doses of fractionated radiotherapy. The primary goal of this research is to determine whether one-day irradiation (a single fraction) is non-inferior to fractionated radiotherapy over a three-month period in terms of pain relief for HSS patients. This study was supported by grant of the Ministry of Health of the Czech Republic AZV NU22-10-00479. All patients signed informed consent.
Material/Methods After completing the enrollment process and filling out the SF-36 questionnaire, as well as the Calcaneodynia score (CS) and visual analogue pain score (VAS) forms, patients (pts) meeting specific inclusion criteria (being over 40 years old, having a diagnosed painful unilateral plantar HSS for at least six months, and being suitable for HSS radiotherapy), and fulfilling the main exclusion criteria (having no prior history of radiotherapy for heel spur, no corticosteroid local application in the four weeks leading up to radiotherapy, no systemic rheumatic or collagen vascular diseases, lymphatic edema of the lower limb, or prior trauma and surgery on the ipsilateral foot), were randomized into six groups based on the total dose of radiotherapy. Patients in these groups received a total dose of 6 Gy in 4 fractions of 1.5 Gy twice weekly (arm A), a total dose of 3 Gy in 2 fractions of 1.5 Gy twice weekly (arm B), a single fraction of 0.5 Gy (arm C), a single fraction of 1.0 Gy (arm D), a single fraction of 1.5 Gy (arm E), and a single fraction of 2 Gy (arm F), respectively. The regimen in arm A (6 Gy in 4 fractions) is commonly used in MMCI and considered as the standard arm. In the event of inadequate pain relief, reirradiation was performed with a total dose of 6 Gy in 4 fractions of 1.5 Gy twice weekly after a waiting period of three months in any of the aforementioned groups.
32 studies on the registry are indexed under Heel Spur; 10 are open to participants now.
This study's planned enrollment of 430 is above the median of 60 across 25 interventional studies indexed under Heel Spur.
Browse Heel Spur studies →Masaryk Memorial Cancer Institute is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
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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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
Total dose of 6 Gy in 2 or 4 single fractions of 1.5 Gy applied twice weekly.
Total dose of 0.5 Gy, 1Gy, 1.5 or 2Gy in 1 single fraction.
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.
Time frame: 44 months
Comparison of different single fraction radiotherapy prescription
Comparison of Calcaneodynia sum score at 3 months after radiotherapy between different single fraction radiotherapy prescription. 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).
Time frame: 44 months
Comparison of the need for reirradiation till 1 year after radiotherapy between fractionated vs. single fraction radiotherapy
To compare the need for reirradiation till 1 year after radiotherapy between fractionated vs. single fraction radiotherapy. To compare the need of reirradiation till 1 year after radiotherapy between different single fraction radiotherapy prescription. Evaluated simply by keeping score of patients returning for irradiation till 1 year after radiotherapy.
Time frame: 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.
Visual analogue scale (VAS) score is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." (0 = no pain, 100 = maximum imaginable pain intensity).SF-36 questionnaire score taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions and single item that provides an indication of perceived change in health. High values indicates good quality of life.
Time frame: 44 months
Evaluation of individual (not sum) parts of Calcaneodynia score and individual domains of quality of life
Evaluation of individual (not sum) parts of Calcaneodynia score and individual domains of quality of life as per outcome 1,2 and 4. Calcaneodynia score form is attached in separate file in this project proposal. 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).
Time frame: 44 months
Analysis of the heel spur radiotherapy techniques in Czechia
Conducting a questionnaire survey analyzing the technique of heel spur radiotherapy at individual workplaces performing this type of treatment in Czechia. The questionnaires will be conducted by Masaryk Memorial Cancer Institute and sent to other facilities in Czechia. Results will be evaluated.
Time frame: 44 months
Plan to share: No
Started Sep 2022 (actual). Primary completion is estimated for May 2025, 32 months after the start.
Of 19 interventional studies with no phase under Heel Spur, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
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Masaryk Memorial Cancer Institute