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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
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

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE April 24, 2018
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE January 23, 2018
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
Numeric Rating Scale [ Time Frame: 12 months ]
Determine pain with the Numeric Rating Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03507010 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ledderhose Disease: Radiotherapy or Not?
Official Title  ICMJE Ledderhose Disease: Radiotherapy or Not? A Randomised, Multicentre, Prospective, Double Blind Phase III Trial Investigating the Effect of Radiotherapy on Patients With Ledderhose Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ledderhose Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Radiotherapy
    Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.
    Intervention: Radiation: Radiotherapy
  • Placebo Comparator: Sham Radiotherapy
    Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated.
    Intervention: Other: Sham Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: R.J.H.M. Steenbakkers, MD, PhD +31(0)503615532 r.steenbakkers@umcg.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03507010
Other Study ID Numbers  ICMJE RT2015-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roel Steenbakkers, University Medical Center Groningen
Study Sponsor  ICMJE University Medical Center Groningen
Collaborators  ICMJE
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Catharina Ziekenhuis Eindhoven
  • Rijnstate Hospital
Investigators  ICMJE Not Provided
PRS Account University Medical Center Groningen
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP