Low-Dose Total Skin Electron Therapy in Treating Patients With Refractory or Relapsed Stage IB-IIIA Mycosis Fungoides
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|ClinicalTrials.gov Identifier: NCT02702310|
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment|
|Recurrent Mycosis Fungoides Refractory Mycosis Fungoides Stage I Mycosis Fungoides Stage II Mycosis Fungoides Stage III Mycosis Fungoides||Other: Quality-of-Life Assessment Other: Objective Grading of Skin Findings|
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.
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|
|Estimated Enrollment :||30 participants|
|Official Title:||Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2020|
Quality of Life/ Grading Skin Findings
Patients' baseline quality of life is established by completion of an initial questionnaire, and skin lesion burden is quantified by physical examination using a recommended system . Following the standard of care radiation therapy, patients' completion of questionnaire, and physical examination is repeated for continued assessment.
Other: Quality-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.
Other: Objective 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.
Other Name: Skindex-29 questionnaire
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702310
|Contact: VICC Clinical Trials Information Program||800-811-8480|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator: Chirayu Patel|
|Principal Investigator:||Chirayu Patel||Vanderbilt-Ingram Cancer Center|