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Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa (RTHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Steven R Cohen, Montefiore Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Hidradenitis Radiation: Low dose Radiotherapy Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

    Grade 5



Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Steven R Cohen, MD, MPH Montefiore Medical Center
  Study Documents (Full-Text)

Documents provided by Steven R Cohen, Montefiore Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] February 5, 2017
Informed Consent Form  [PDF] July 13, 2016

More Information
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Additional Information:

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Responsible Party: Steven R Cohen, Chief of Dermatology at Montefiore, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03040804    
Other Study ID Numbers: 2016-7228
First Posted: February 2, 2017    Key Record Dates
Results First Posted: October 20, 2021
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Steven R Cohen, Montefiore Medical Center:
hidradenitis suppurativa
HS
radiotherapy
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration