Clinical Trial: Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique

Brief 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.

Detailed Summary:

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.


Sponsor: Vanderbilt-Ingram Cancer Center

Current Primary Outcome: Change in skin-related quality of life assessed by Skindex-29 [ Time Frame: Baseline to up to 3 years ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in the durability of response assessed by mSWAT tool [ Time Frame: Baseline to up to 3 years ]
    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.
  • Incidence of side effects of low dose total skin electron therapy administered via rotisserie technique [ Time Frame: Up to 3 years ]
    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.


Original Secondary Outcome: Same as current

Information By: Vanderbilt-Ingram Cancer Center

Dates:
Date Received: February 29, 2016
Date Started: April 2016
Date Completion: March 2020
Last Updated: November 1, 2016
Last Verified: November 2016