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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Rijnstate Hospital | OTHER |
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The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Experimental | Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy. |
|
| Sham Radiotherapy | Placebo Comparator | Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Patients randomized to the Radiotherapy arm will be treated with electrons and receive a total dose of 30 Gy (two separate courses of five daily fractions of 3.0 Gy each). |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale | Determine pain with the Numeric Rating Scale | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale | Determine pain with the Numeric Rating Scale | 6 and 18 months |
| Size of ledderhose nodules | Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9700RB | Netherlands |
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| ID | Term |
|---|---|
| D000071380 | Fibromatosis, Plantar |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Sham Radiotherapy | Other | Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated. |
|
| 12 months |
| Walking distance | Determine the effect of radiotherapy on walking distance with the 10 meter straight line walk test | 6, 12 and 18 months |
| Walking motion | Determine the effect of radiotherapy on walking motion with the PEDAR-X® in shoe pressure measurement system | 12 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Assess the safety and toxicity of radiotherapy on this population by recording the toxicity of radiotherapy during the course of radiotherapy and thereafter measured by CT-CAE 4.0. | 18 months |
| Quality of life (1) | Assess the impact on quality of life of radiotherapy as treatment for this study population with RAND-36 item Health Survey questionnaire | 6, 12 and 18 months |
| Quality of life (2) | Assess the impact on quality of life of radiotherapy as treatment for this study population with the brief pain inventory questionnaire | 6, 12 and 18 months |
| Quality of life (3) | Assess the impact on quality of life of radiotherapy as treatment for this study population with the EURO-Qol-5D questionnaire | 6, 12 and 18 months |
| Cost-effectiveness analysis (CEA) | The economic evaluation will be performed from a societal perspective, incorporating cost of travel to the hospital and cost of absence from work as well as direct medical cost of radiotherapy (cost of irradiation and outpatient visits). Questionnaires will be used to collect data regarding health care consumption, travel and time costs, and productivity loss at study entry and at 6-month intervals thereafter. In addition to the pain scores, quality of life will be assessed at 6-month intervals using the Rand-36 questionnaire. The utilities based on the results of the questionnaire will be used in a cost-utility analysis, calculating the ratio of incremental costs versus incremental quality-adjusted life-years (QALY). | 6, 12 and 18 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |