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Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa (RTHS)

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ClinicalTrials.gov Identifier: NCT03040804
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Steven R Cohen, Montefiore Medical Center

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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)
Primary Purpose: Treatment
Official Title: A Phase I Study of Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




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 Grade ≥3 adverse events during radiotherapy or within 3 months of radiotherapy completion, assessed using CTCAE version 4.0


Secondary Outcome Measures :
  1. Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS) measures, including pain interference and physical functioning at 3 months (and optionally at 6 months and 12 months) after treatment [ Time Frame: 6 months - 1 year post treatment ]
    examine the efficacy of radiotherapy in improvement of quality of life

  2. Evaluation of lesional histological changes associated with radiotherapy using H&E and immunohistochemistry stains on punch biopsy specimens. [ Time Frame: 3-6 months post treatment ]
    Explore histological changes following radiotherapy for advanced hidradenitits suppurativa



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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

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


Contacts
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Contact: Steven R Cohen, MD, MPH 718-944-0807 srcohen@montefiore.org
Contact: Fiona M Shaw, MD 718-944-0807 fshaw@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Steven R Cohen, MD, MPH    718-944-8255    srcohen@montefiore.org   
Contact: Fiona M Shaw, MD    718-944-8255    fshaw@montefiore.org   
Sub-Investigator: Nitin Ohri, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Steven R Cohen, MD, MPH Montefiore Medical Center

Additional Information:
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Responsible Party: Steven R Cohen, Chief of Dermatology at Montefiore, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03040804     History of Changes
Other Study ID Numbers: 2016-7228
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration