Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

Study Overview
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Brief Summary
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To establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months.

Detailed Description
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This is a phase I clinical trial using a Simon-two stage design to establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa (HS). In the first six months, 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. A maximum of 20 patients will be enrolled. Patients will be treated with skin-directed radiotherapy, using a total prescription dose of 7.5 Gy in five fractions of 1.5 Gy over one week. Patients will then be seen in the HS specialty clinic at Montefiore Medial Center for at least three months. Quality of life changes, immunohistochemical changes, and cutaneous discharge will also be evaluated during the study period.

Official Title
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A Phase I Study of Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa, Hidradenitis

Intervention / Treatment
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* Radiation: Low dose Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Hidradenitis Suppurativa made at the Montefiore Hidradenitis Suppurativa Treatment Center, with Hurley Stage 2-3 (defined as recurrent abscesses or boils with diffuse or broad involvement, multiple interconnected sinus tracts in the whole area) Failed maximal medical therapy for Hidradenitis Suppurativa or ineligible for standard medical therapy or surgery Age > 20 years Women of childbearing age: must have a negative pregnancy test within 72 hours prior to the start of study therapy and agree to an adequate method of contraception throughout treatment and for at least 4 weeks after study contraception. Exclusion Criteria: Pregnant women Individuals < 20 years old

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose Radiotherapy<br>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<br>* 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.<br>* Other names: Brachytherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. Grade 5 | follow up for 3-6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS). | 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. | 6 months - 1 year post treatment | 
| Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions. | 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. | 3-6 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hidradenitis suppurativa, HS, radiotherapy