Radiotherapy for Treatment of Recalcitrant Hidradenitis Suppurativa (RADIANT-SUPPoRT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in HS Disease Activity
研究概览
简要总结
The goal of this clinical trial is to learn if high-dose radiotherapy can provide sustained disease relief in moderate to severe, treatment resistant Hidradenitis suppurativa patients; could include any of the following: any sex/gender, and those greater then 18 years old. The main question[s] it aims to answer are:
Outcome measure 1: Will radiotherapy change the number of inflammatory nodules, abscesses, and draining sinus tracts in the treated axilla compared with the untreated axilla? Outcome measure 2: Will radiotherapy positively change a patient's quality of life, pain levels and symptom burden?
Participants will receive radiotherapy to one axilla affected by hidradenitis suppurativa. The contralateral axilla will not receive radiotherapy and will continue receiving the standard treatment regimen.
Participants will...
- Attend a baseline dermatology skin evaluation, complete multiple surveys and an optional participation in a biopsy
- Attend multiple radiation sessions over 5 weeks
- Attend 2 follow up visits with dermatology for skin evaluation, complete follow up surveys, and an optional biopsy.
详细描述
This is a prospective, non-randomized, split-body interventional study enrolling adults with moderate to severe hidradenitis suppurativa involving bilateral axillary disease of comparable severity. Each participant will receive radiotherapy to one axilla, while the contralateral axilla will serve as an untreated within-subject control.
Radiotherapy will be delivered to a total dose of 45 Gy in 15 fractions (3 Gy per fraction), administered three times per week over approximately five weeks.
Patients will continue stable background HS therapies during the study period. Dermatologic assessments, lesion counts, physician global assessment scores, and patient-reported outcomes will be collected at baseline, during treatment, and at 4 and 12 weeks following completion of radiotherapy. Long-term safety and disease outcomes will be assessed by chart review for up to two years post-treatment. An optional punch biopsy sub-study will evaluate histologic changes associated with treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between the age of 18 or older with moderate or severe HS (Hurley Stage II or III) with bilateral axillary disease of approximately equivalent disease severity will be included.
- •Patients on topical and/or systemic HS medications for at least 1 month will continue maintenance treatment throughout the study period as per standard of care.
- •Patients willing and able to provide informed consent
排除标准
- •Pregnancy - Women of childbearing potential must use trial approved birth control and obtain a negative pregnancy test 7 days prior to radiotherapy CT simulation.
- •Severe autoimmune conditions including lupus, scleroderma and mixed connective tissue disease
- •Poorly controlled diabetes per physician discretion, HIV, Hepatitis B/C.
- •Prior therapeutic radiotherapy.
- •Active malignancy.
- •Contraindication to radiotherapy as determined by treating radiation oncologist.
- •Patients who began new systemic treatment for their HS <1 month prior to enrollment in trial
- •History of photosensitivity disorders or prior radiation sensitization syndromes
- •Any contraindication to radiotherapy as determined by the treating radiation oncologist.
研究组 & 干预措施
Radiation axilla
Participants will receive radiotherapy to one axilla affected by hidradenitis suppurativa.
干预措施: Radiated axilla (Radiation)
Non-radiated Axilla
The contralateral axilla will not receive radiotherapy and will continue on the current standard of care.
结局指标
主要结局
Change in HS Disease Activity
时间窗: Baseline (within 7 days prior to first radiotherapy treatment) to 12 weeks after completion of radiotherapy
Change in the number of inflammatory nodules, abscesses, and draining sinus tracts in the treated axilla compared with the untreated axilla.
次要结局
- Dermatology Life Quality Index (DLQI)(Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy)
- Pain and Symptom Burden (Numerical Rating Scale)(Baseline, 4 weeks post-radiotherapy, and 12 weeks post-radiotherapy)
- Duration Without HS Flare(Up to 2 years post-radiotherapy (chart review))
- Radiation-Related Toxicities(During radiotherapy and through 12 weeks post-treatment)
- Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score(Baseline (within 1 week of first radiotherapy treatment) and 4 weeks after completion of radiotherapy)
- Response Rates(12 weeks post-radiotherapy)
- Optional: Histopathological Characterization in Treated Skin(Baseline and 12 weeks post-radiotherapy biopsies. This is only in the subset of participants that agreed to participate in this arm of the trial.)
研究者
Gregory Alexander
Principal Investigator
Thomas Jefferson University