Ledderhose Disease: Radiotherapy or Not?

Ledderhose Disease Clinical Trial

— LedRad  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03507010
• Other study ID #: RT2015-03
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 23, 2018
• Est. completion date: March 15, 2029

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: March 15, 2029
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ledderhose Disease

Intervention

Radiation:
• Radiotherapy
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).

Other:
• Sham Radiotherapy
Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (4)

Lead Sponsor	Collaborator
University Medical Center Groningen	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catharina Ziekenhuis Eindhoven, Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale	Determine pain with the Numeric Rating Scale	12 months
Secondary	Numeric Rating Scale	Determine pain with the Numeric Rating Scale	6 and 18 months
Secondary	Size of ledderhose nodules	Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound	12 months
Secondary	Walking distance	Determine the effect of radiotherapy on walking distance with the 10 meter straight line walk test	6, 12 and 18 months
Secondary	Walking motion	Determine the effect of radiotherapy on walking motion with the PEDAR-X® in shoe pressure measurement system	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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