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.
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 investigational portion of this research study involves collecting quality of life (QOL) questionnaire data and objective measurements of patients' skin responses, which are obtained by the radiation oncologist during the patient's standard of care radiation treatment planning. Patients will also undergo standard of care low-dose total skin electron therapy for under 1 hour daily on days 10-21. After completion of study treatment, patients are followed up at 6 and 12 weeks, and then every 3 months thereafter.
Study Type
OBSERVATIONAL
Enrollment
60
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.
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.
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Change in skin-related quality of life assessed by Skindex-29
Skindex-29 is a validated quality of life questionnaire to help quantify how mycosis fungoides may affect one's quality of life on a day to day basis, including emotional impact of the skin disease.
Time frame: Baseline to up to 3 years
Change in the durability of response assessed by mSWAT tool
mSWAT is the Modified Severity Weighted Assessment Tool used by the radiation oncologist during complete physical examination to quantify skin findings of patches, plaques, and tumors in all regions of the body; this would help the radiation oncologist and dermatologist to better follow the response to treatment.
Time frame: Baseline to up to 3 years
Incidence of side effects of low dose total skin electron therapy administered via rotisserie technique
The patient will be closely monitored by the radiation oncologist during treatment, with at least 2-3 visits while patient is on treatment. Side effects will be documents in patient medical records.
Time frame: Up to 3 years
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