Clinical trial NCT06330545: Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
Official title: A Prospective Clinical Trial of Radiation Therapy for Dupuytren's Contracture Following Surgical and Non-Surgical Release
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dupuytren Contracture
Keywords: Dupuytren's contracture
radiation therapy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 95
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful CCH injection and release will receive a standardized regimen of radiotherapy (RT). The study will be powered to assess the outcome in patients undergoing the combination of successful release followed by RT. Patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a \> 20 degree worsening of contracture in the presence of a palpable cord, or the need for medical/surgical intervention to correct the new or worsening contracture.
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful Collagenase Clostridium Histolyticum (CCH) injection and release will receive a standardized regimen of adjuvant radiotherapy (RT). The study will be powered to assess the outcome in patients undergoing the combination of successful release followed by RT. Patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a \> 20 degree worsening of contracture in the presence of a palpable cord as compared to within 14 days from CCH injection, or the need for medical/surgical intervention to correct the new or worsening contracture.

Eligibility criteria: Inclusion Criteria:

* 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.
* For patients who are having multiple CCH injections, only the first 2 joints on given hand will be included

Exclusion Criteria:

* 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.
* Less than the age of 45
* They have previously undergone radiation on the hand in which they plan to get CCH injections
* They are pregnant women, impaired adults or prisoners

Primary outcomes:
measure: Recurrence of Dupuytren's Contracture
timeFrame: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Secondary outcomes:
measure: Radiation Toxicity
timeFrame: one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
measure: Patient Reported Outcomes after Radiation Treatment (RT)
timeFrame: 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-RT
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock
state: New Hampshire
Study officials:
affiliation: Dartmouth Health
name: Lance Warhold, MD
role: PRINCIPAL_INVESTIGATOR
References: