Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
ConditionDupuytren Contracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorDartmouth-Hitchcock Medical Center
About this trial
The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are:
• Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum?
Participants will undergo:
* Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection * Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 45 or greater with DC
Extension deficit >10 degrees
Unable to simultaneously place the affected finger and palm flat on a table.
Women included in the study will be post-menopausal or using contraception, and a pregnancy test will be performed as standard of care.
Disqualifiers
Unsuccessful non-surgical release (> N/1 disease)
They develop an open wound during CCH
Breast feeding or pregnancy
A chronic muscular, neurologic, or neuromuscular disorder affecting the hands.
Trial design
Design model
Single group
Treatments tested in this trial
Radiation therapy
RadiationPatients with Dupuytren's Contacture will undergo Collagenase Clostridium Histolyticum injection and release followed by two 5-day courses of radiation therapy separated by 6-8 weeks. They will then be followed for 3 years for recurrence.
Treatment groups
95 Participants
are divided into 1 treatment groupGroup A: Patients with Dupuytren's ContactureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence of Dupuytren's Contracture
Recurrence defined as \> 20 degrees worsening of contracture relative to within 14 days from CCH injection or the need for medical/surgical intervention to correct the new or worsening symptomatic contracture. The investigators will measure the contracture using the table top test in which patients their press hand with best of their ability. We will use a goniometer on dorsal surface of hand while performing table top test to measure PIP and MCP joints.
Time frame
one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatmentSecondary outcomes
1
Radiation Toxicity
acute (30 days or less) and late (\> 30 days) Grade 2 and Grade 3 toxicities from radiotherapy defined by Radiation Therapy Oncology Group
Time frame
one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment2
Patient Reported Outcomes after Radiation Treatment (RT)
The investigators will also record hand function change from baseline to after therapy via the Brief Michigan Hand Questionnaire, a patient reported outcome measure. This questionnaire will be used before study enrollment, after completion of RT, one-month post-RT, six months post-RT, one year post-RT, two years post-RT, and three years post-RT. The Michigan Hand Questionnaire is scored from 0-100 with higher scores indicating better functioning and satisfaction.
Time frame
Before Radiation Treatment (RT), after completion of RT, 1-month post-RT, 6 months post-RT, 1 year post-RT, 2 years post-RT, and 3 years post-RTSponsors and contacts
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Source ClinicalTrials.gov