Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release

Dupuytren Contracture Clinical Trial

Official title:

A Prospective Clinical Trial of Radiation Therapy for Dupuytren's Contracture Following Surgical and Non-Surgical Release

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06330545
• Other study ID #: STUDY02002161
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2032

Study information

• Verified date: March 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Julia S Schwarz, MD
• Phone: 603 650-5133
• Email: julia.s.schwarz[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 95
• Est. completion date: April 2032
• Est. primary completion date: April 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture

Intervention

Radiation:
• Radiation therapy
Patients 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; We 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.	one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Secondary	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	one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Secondary	Patient Reported Outcomes after Radiation Treatment (RT)	We 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.	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