Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique
Vanderbilt-Ingram Cancer Center
Summary
This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.
Description
PRIMARY OBJECTIVES: I. To assess the skin-related quality of life using an established method (Skindex-29), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments. II. To assess the durability of response using an established method (modified Severity-Weight Assessment \[mSWAT\] tool), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments. III. To determine side effect profile for low dose total skin electron therapy (TSE) for mycosis fungoides administered via rotisserie technique. OUTLINE: The investi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- OtherQuality-of-Life Assessment
At initial visit (day 1) - for determination of a baseline quality of life, patients will be given a self-reported questionnaire called the Skindex-29. Following standard of care radiation treatments, at weeks 6 \& 12, and every 3 months thereafter, patients will complete the Skindex-29 questionnaire.
- OtherObjective Grading of Skin Findings
At initial visit (day 1) , using mSWAT the radiation oncologist can follow the patient's treatment response by accurately grading the severity of the patient's skin findings. Following standard of care radiation treatments, at weeks 6 \& 12, and every 3 months thereafter, mSWAT will again be determined by physician. Follow-up visits will continue until patient has a change in disease.
Location
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee