Low-dose electron therapy for treating refractory or relapsed mycosis fungoides
Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique
This study is testing a low-dose skin treatment for people with stubborn or returning mycosis fungoides to see if it can improve their skin and quality of life while causing fewer side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT02702310 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of low-dose total skin electron therapy in patients with stage IB-IIIA mycosis fungoides that has either not responded to previous treatments or has returned after improvement. The therapy is administered using a rotisserie technique, allowing for a more uniform treatment of the skin while potentially minimizing side effects. The study aims to assess the impact on skin-related quality of life and the durability of treatment response, alongside monitoring side effects. Patients will receive treatment for under an hour daily over a period of 10 to 21 days, followed by regular follow-up assessments.
Who should consider this trial
Good fit: Ideal candidates include individuals with biopsy-confirmed stage IB-IIIA mycosis fungoides that has not responded to or has relapsed after at least one prior therapy.
Not a fit: Patients with serious medical conditions that would make treatment unsafe or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the quality of life and skin condition for patients suffering from refractory or relapsed mycosis fungoides.
How similar studies have performed: While this approach is innovative, similar studies using electron therapy have shown promise in treating skin-related malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy confirmed mycosis fungoides stage IB-IIIA * Skin manifestations of mycosis fungoides that are refractory to or have relapsed on at least one prior therapy, which may include topical steroids * Life expectancy \> 6 months Exclusion Criteria: * Serious medical condition that would make treatment unsafe * Pregnant or lactating patient
Where this trial is running
Nashville, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Austin Kirschner, MD, PhD — Vanderbilt-Ingram Cancer Center
- Study coordinator: VICC Clinical Trials Information Program
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.