Ledderhose Disease: Radiotherapy or Not?

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Ledderhose Disease: Radiotherapy or Not? A Randomised, Multicentre, Prospective, Double Blind Phase III Trial Investigating the Effect of Radiotherapy on Patients With Ledderhose Disease

Conditions
-----------------
Ledderhose Disease

Intervention / Treatment
-----------------
* Radiation: Radiotherapy
* Other: Sham Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain). Age ≥ 18 years WHO performance status 0, 1 or 2 (Appendix, section 18) Before patient randomisation, written informed consent must be given according to ICH/GCP, and WMO requirements. Controlling the Dutch language (speaking and reading). Able and willing to complete quality of life questionnaires in Dutch Must be accessible for treatment follow-up Exclusion Criteria: Surgical intervention before for Ledderhose disease Previous radiation treatment for Ledderhose disease Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Not able to lay prone for at least fifteen minutes Females who are pregnant at entry or who want to become pregnant within six months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy<br>Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy. | Radiation: Radiotherapy<br>* 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).<br>|
| Placebo Comparator: Sham Radiotherapy<br>Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated. | Other: Sham Radiotherapy<br>* Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale | Determine pain with the Numeric Rating Scale | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Pain