Trial Outcomes & Findings for Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa (NCT NCT03040804)

Last Updated: 2021-11-01

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

follow up for 3-6 months post treatment

Results posted on

2021-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Radiotherapy n=2 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Improvement in hidradenitis suppurativa lesion size	2 participants n=5 Participants

PRIMARY outcome

Timeframe: follow up for 3-6 months post treatment

Population: Patients with Hidradenitis Suppurativa (HS) Hurley Stage 2-3.

Outcome measures

Outcome measures
Measure	Low Dose Radiotherapy n=2 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Low Dose Radiotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven R. Cohen, MD, MPH

Montefiore Medical Center

Phone: 7189208352

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place