RecruitingRecruiting
Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides
NCT02702310 · Vanderbilt-Ingram Cancer Center
In plain English
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Official title
Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique
About this study
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.
Eligibility 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
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2016-05-22
Estimated completion: 2026-09
Last updated: 2025-03-28
Interventions
Other: Quality-of-Life AssessmentOther: Objective Grading of Skin Findings
Primary outcomes
- • Change in skin-related quality of life assessed by Skindex-29 (Baseline to up to 3 years)
Sponsor
Vanderbilt-Ingram Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactVICC Clinical Trials Information Program · contact · 800-811-8480
InvestigatorAustin Kirschner, MD, PhD · principal_investigator, Vanderbilt-Ingram Cancer Center
All locations (1)
Vanderbilt-Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States