Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— RTHS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03040804
• Other study ID #: 2016-7228
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 21, 2020

Study information

• Verified date: October 2021
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Montefiore Hidradenitis Suppurativa Multispecialty clinic