Radiation Therapy for Dupuytren's Disease

(Dupuytren's Trial)

BM
Overseen ByBruce McGibbon, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether radiation therapy can prevent Dupuytren's disease from worsening or recurring. Dupuytren's disease causes thickened tissue in the hand, leading to fingers bending inward. Participants will either receive radiation therapy or continue their usual care to determine which approach is more effective. Individuals with early-stage Dupuytren's disease, without finger bending and no prior hand radiation, may qualify for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that radiation therapy is likely to be safe for humans?

Research shows that radiation therapy is a common cancer treatment, using high-energy rays to target and damage cells. Although it can also affect healthy cells, these cells typically recover more easily than cancer cells.

Patients who undergo radiation therapy often report side effects like skin irritation and tiredness, which are usually mild and temporary. Importantly, radiation therapy has been used safely in many medical settings, demonstrating that it is generally well-tolerated.

Radiation therapy is a standard medical treatment with well-documented safety. This trial explores its potential to help with Dupuytren's disease, a condition affecting the hands. Overall, existing research suggests that the treatment is safe, though some temporary side effects might occur.12345

Why do researchers think this study treatment might be promising for Dupuytren's disease?

Researchers are excited about using radiation therapy for Dupuytren's Disease because it offers a non-surgical option for early-stage patients. Unlike traditional treatments, such as surgery or enzyme injections, radiation therapy aims to slow or stop the progression of the disease before it leads to finger contractures. This approach could potentially preserve hand function without the need for invasive procedures, making it a promising alternative for those in the early stages of the condition.

What evidence suggests that radiation therapy might be an effective treatment for Dupuytren's disease?

Research has shown that radiation therapy can help treat Dupuytren's disease. In one review, 65% of patients noticed symptom improvement after radiation. Another study found that 92% of patients maintained stable conditions, with 75% experiencing fewer symptoms. Long-term data suggests that radiation therapy can prevent the disease from worsening over time. Many patients reported satisfaction with their results, indicating effective treatment. In this trial, participants with early-stage Dupuytren's disease will receive either radiation therapy or standard care. Overall, evidence supports radiation therapy as a promising option for managing early-stage Dupuytren's disease.678910

Who Is on the Research Team?

BM

Bruce McGibbon, MD

Principal Investigator

Yale University

FD

Frank D Buono, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Dupuytren's disease or contracture who want to see if radiation can help prevent their condition from getting worse. Specific inclusion and exclusion criteria are not listed, so eligibility may depend on a doctor's assessment.

Inclusion Criteria

Patient consent
English-speaking
I do not have any diseases that make me sensitive to radiation.
See 5 more

Exclusion Criteria

Pregnancy or lactation
I have a genetic condition that makes me very sensitive to radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy to reduce the risk of progression/recurrence of Dupuytren's disease

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

108 months
Regular visits at 6, 12, 24, 36, 48, 60, 84, and 108 months

What Are the Treatments Tested in This Trial?

Interventions

  • Radiation Therapy

Trial Overview

The study randomly assigns participants to receive either radiation therapy or standard care to find out if radiation helps stop Dupuytren's disease from progressing or coming back.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Radiation TherapyExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Citations

Toxicities and Quality of Life following Observation or ...

Long-term results after 13 years. Dupuytren's contracture (DC) is a fibroproliferative disorder that can result in functional impairment of the hand.

Case Study - Radiation Therapy for Dupuytren's Disease

Radiation therapy helped shrink hand nodules and improve functionality. The brief course of treatment reduced the size of nodules on his hands ...

Radiation Therapy for Dupuytren Disease: A Systematic ...

When evaluating the outcomes of all qualifying studies, 13 out of the 20 (65%) reported the regression of patient symptoms as the most frequent ...

Dupuytren's Contracture Treatment: Low-Dose Radiotherapy

Radiotherapy for Dupuytren's contracture uses lower doses of radiation than radiotherapy for cancers, so it's much safer with almost no side ...

Radiation Therapy for Dupuytren's Contracture

The authors concluded that after a mean follow- up of 13 years, radiotherapy is effective in prevention of disease progression and improves patients' symptoms

Radiation Therapy for Cancer - NCI

Radiation therapy does not kill cancer cells right away. It takes days or weeks of treatment before DNA is damaged enough for cancer cells to ...

What is Radiation?

In high doses, ionizing radiation can damage cells or organs in our bodies or even cause death. Some gamma rays pass right through the human ...

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