Prospective observational trial of low-dose skin electron beam therapy in mycosis fungoides using a rotational technique.
Neil B Newman, Chirayu G Patel, George X Ding...
https://pubmed.ncbi.nlm.nih.gov/33333150Actively Recruiting
Age: 18Years +
All Genders
ID02702310
Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique
Led by Vanderbilt-Ingram Cancer Center · Updated on 2025-03-28
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating low-dose total skin electron therapy using the rotisserie technique in patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatments or has returned after improvement. This approach uses radiation to target tumor cells on the skin, aiming to reduce side effects and allow for repeated treatments if needed. The study focuses on assessing quality of life, treatment response durability, and side effects. Participants receive low-dose total skin electron therapy daily for under one hour from days 10 to 21 while standing on a rotating platform. Quality of life is measured using the Skindex-29 questionnaire, and skin response is graded using the modified Severity-Weight Assessment (mSWAT) tool. After treatment, patients are followed up at 6 and 12 weeks, then every 3 months to monitor ongoing effects and any disease changes. During the study, patients complete questionnaires and undergo physical examinations by a radiation oncologist to assess skin condition and treatment impact. Researchers track changes in quality of life and skin lesion severity over up to three years. Side effects of the therapy are also monitored throughout this period. The total participation time varies with follow-up continuing until disease changes are observed.
CONDITIONS
Brief Title
Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 greater than 6 months
- Age 18 years or older
You will not qualify if you...
- Serious medical condition that would make treatment unsafe
- Pregnant or lactating patient
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 days
Participants receive standard of care low-dose total skin electron therapy daily on days 10 to 21, lasting under 1 hour each day.
Daily visits for up to 12 days
Long-term Monitoring
Duration - Up to 3 years
After treatment, participants complete quality of life questionnaires and undergo skin assessments to monitor skin response and side effects over time.
Visits at 6 and 12 weeks, then every 3 months thereafter
Trial Site Locations
Total: 1 location
1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
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Research Team
V
VICC Clinical Trials Information Program
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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