Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa (RTHS)
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|ClinicalTrials.gov Identifier: NCT03040804|
Recruitment Status : Terminated (Infeasibility to continue study.)
First Posted : February 2, 2017
Results First Posted : October 20, 2021
Last Update Posted : November 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa Hidradenitis||Radiation: Low dose Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Simon two-stage design. In the first stage, 6 patients will be enrolled. If the patients in the study do not meet the termination criteria then the study will extend to a second stage and a maximum of 20 patients will be enrolled.|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||December 21, 2020|
|Actual Study Completion Date :||December 21, 2020|
Experimental: Low Dose Radiotherapy
Patients will receive skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week
Radiation: Low dose Radiotherapy
Subjects in this protocol will only receive radiotherapy directed at one region, typically the region that is most bothersome to the patient. Patients will receive a total radiotherapy dose 7.5 Gy in five daily fractions of 1.5 Gy.
Other Name: Brachytherapy
- Number of Participants With HS Who Experience Treatment-related Grade ≥3 Adverse Events During Radiotherapy or Within 3 Months of Radiotherapy Completion, Assessed Using CTCAE Version 4.0 [ Time Frame: follow up for 3-6 months post treatment ]
Number of participants with HS who experience treatment-related CTCAE version 4.0 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion. Common Terminology Criteria for Adverse Events (CTCAE) is an internationally accepted standard for defining and categorizing adverse events based on severity of reported adverse events. The grading scheme is from 1 (least severe) to 5 (most severe). For radiotherapy associated adverse events, CTCAE version 4.0 will be applied to "Rash: dermatitis associated with radiation".
Grade 1. Mild: Faint erythema or dry desquamation. Grade 2. Moderate: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema.
Grade 3. Severe: Moist desquamation other than skin folds and creases; bleeding induced by minor trauma or abrasion.
Grade 4. Life threatening: Skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site.
- Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS). [ Time Frame: 6 months - 1 year post treatment ]Evaluation of the efficacy of radiotherapy in improvement of patient's quality of life using patient reported outcome measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment.
- Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions. [ Time Frame: 3-6 months post treatment ]Hematoxylin and Eosin (H&E) stain and immunohistochemistry stains will be performed on skin biopsy specimens to investigate histological changes following radiotherapy for advanced hidradenitis suppurativa lesions.
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): NCT03040804
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Steven R Cohen, MD, MPH||Montefiore Medical Center|