Ledderhose Disease: Radiotherapy or Not?

Phase 3Active Not RecruitingNCT03507010

University Medical Center Groningen84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Ledderhose Disease

Interventions

RadiotherapyRADIATION

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).

Sham RadiotherapyOTHER

Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

Numeric Rating Scale

Determine pain with the Numeric Rating Scale

Time frame: 12 months

Secondary Outcomes

Numeric Rating Scale

Determine pain with the Numeric Rating Scale

Time frame: 6 and 18 months

Size of ledderhose nodules

Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound

Time frame: 12 months

Walking distance

Determine the effect of radiotherapy on walking distance with the 10 meter straight line walk test

Time frame: 6, 12 and 18 months

Walking motion

Determine the effect of radiotherapy on walking motion with the PEDAR-X® in shoe pressure measurement system

Time frame: 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.

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.