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Ledderhose Disease: Radiotherapy or Not? (LedRad)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507010
Recruitment Status : Active, not recruiting
First Posted : April 24, 2018
Last Update Posted : November 8, 2021
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Catharina Ziekenhuis Eindhoven
Rijnstate Hospital
Information provided by (Responsible Party):
Roel Steenbakkers, University Medical Center Groningen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ledderhose Disease Radiation: Radiotherapy Other: Sham Radiotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Primary Completion Date : August 15, 2021
Estimated Study Completion Date : January 15, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Radiotherapy
Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.
 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).
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.


Outcome Measures
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Primary Outcome Measures :
  1. Numeric Rating Scale [ Time Frame: 12 months ]
    Determine pain with the Numeric Rating Scale


Secondary Outcome Measures :
  1. Numeric Rating Scale [ Time Frame: 6 and 18 months ]
    Determine pain with the Numeric Rating Scale

  2. Size of ledderhose nodules [ Time Frame: 12 months ]
    Determine the effect of radiotherapy on size of Ledderhose nodules with MRI and Ultrasound

  3. 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

  4. Walking motion [ Time Frame: 12 months ]
    Determine the effect of radiotherapy on walking motion with the PEDAR-X® in shoe pressure measurement system

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Catharina Ziekenhuis Eindhoven
Rijnstate Hospital
More Information
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Responsible Party: Roel Steenbakkers, MD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03507010    
Other Study ID Numbers: RT2015-03
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roel Steenbakkers, University Medical Center Groningen:
Radiotherapy
Pain
Additional relevant MeSH terms:
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Fibromatosis, Plantar
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Foot Diseases
Musculoskeletal Diseases
Contracture
Muscular Diseases
Connective Tissue Diseases
Skin Diseases