Hidradenitis Suppurativa, Hidradenitis
Conditions
Keywords
hidradenitis suppurativa, HS, radiotherapy
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.
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.
Interventions
RADIATIONLow 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.
Sponsors
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS). | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Low Dose Radiotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 70 years |
| Improvement in hidradenitis suppurativa lesion size | 2 participants |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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
Time frame: follow up for 3-6 months post treatment
Population: Patients with Hidradenitis Suppurativa (HS) Hurley Stage 2-3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Radiotherapy | 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 | 2 Participants |
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.
Time frame: 6 months - 1 year post treatment
Population: Due to COVID-19 pandemic, patient safety was prioritized and the study was terminated early. Participant outcome measures were not performed.
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.
Time frame: 3-6 months post treatment
Population: Due to COVID-19 pandemic, patient safety was prioritized and the study was terminated early. Participant outcome measures were not completed.