Ledderhose Disease: Radiotherapy or Not? (LedRad)
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|ClinicalTrials.gov Identifier: NCT03507010|
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ledderhose Disease||Radiation: Radiotherapy Other: Sham Radiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 23, 2018|
|Estimated Primary Completion Date :||April 15, 2021|
|Estimated Study Completion Date :||April 15, 2021|
Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.
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).
Placebo Comparator: Sham Radiotherapy
Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated.
Other: Sham Radiotherapy
Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.
- Numeric Rating Scale [ Time Frame: 12 months ]Determine pain with the Numeric Rating Scale
- Numeric Rating Scale [ Time Frame: 6 and 18 months ]Determine pain with the Numeric Rating Scale
- Size of ledderhose nodules [ Time Frame: 12 months ]Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound
- Walking distance [ Time Frame: 6, 12 and 18 months ]Determine the effect of radiotherapy on walking distance with the 10 meter straight line walk test
- Walking motion [ Time Frame: 12 months ]Determine the effect of radiotherapy on walking motion with the PEDAR-X® in shoe pressure measurement system
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 18 months ]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.
- Quality of life (1) [ Time Frame: 6, 12 and 18 months ]Assess the impact on quality of life of radiotherapy as treatment for this study population with RAND-36 item Health Survey questionnaire
- Quality of life (2) [ Time Frame: 6, 12 and 18 months ]Assess the impact on quality of life of radiotherapy as treatment for this study population with the brief pain inventory questionnaire
- Quality of life (3) [ Time Frame: 6, 12 and 18 months ]Assess the impact on quality of life of radiotherapy as treatment for this study population with the EURO-Qol-5D questionnaire
- Cost-effectiveness analysis (CEA) [ Time Frame: 6, 12 and 18 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507010
|Contact: R.J.H.M. Steenbakkers, MD, PhD||+31(0)email@example.com|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9700RB|
|Contact: R.J.H.M. Steenbakkers, MD, PhD +31(0)503615532 firstname.lastname@example.org|