Ledderhose Disease: Radiotherapy or Not?

Phase 3

Active, not recruiting

• Conditions: Ledderhose Disease
• Interventions: Other: Sham Radiotherapy; Radiation: Radiotherapy

• Registration Number: NCT03507010
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-01-23
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-24
• Primary Completion: 2021-08-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Completion: 2029-03-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Radiotherapy	Sham Radiotherapy	Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated.
Radiotherapy	Radiotherapy	Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	12 months	Determine pain with the Numeric Rating Scale

Secondary Outcome Measures

Name	Time	Method
Walking motion	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	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.
Numeric Rating Scale	6 and 18 months	Determine pain with the Numeric Rating Scale
Walking distance	6, 12 and 18 months	Determine the effect of radiotherapy on walking distance with the 10 meter straight line walk test
Quality of life (1)	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)	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)	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
Size of ledderhose nodules	12 months	Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound
Cost-effectiveness analysis (CEA)	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).

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands