A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Common Terminology Criteria for Adverse Events (CTCAE) v4.0
研究概览
简要总结
Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Site investigators will load the digital photographs taken at each weekly assessment into each participant's MOSAIQ record. They will then send de-identified copies to the Central Trial Coordinator who will distribute them to the study investigators who will be performing the blinded assessment. Each weekly photograph will be independently assessed by two study investigators using the CTCAE 4.0 scale for radiation dermatitis (Appendix 1). The study investigators will complete the supplied photograph assessment form and return them to the Central Trial Coordinator.
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
- •Patients with cancer undergoing a curative course of radiation therapy using standard protocols to the following cancer sites:
- •Head and neck cancers receiving >= 60Gy who are not receiving concurrent Cetuximab
- •Intact breast receiving >= 40Gy (includes patients receiving boost fields using photon or elections)
- •Post-mastectomy chest wall (breast cancer diagnosis only) receiving >= 50Gy
- •Gynaecological cancers requiring whole pelvis irradiation receiving >= 45Gy
- •Skin cancers to the axilla/groin regions receiving >= 40Gy
- •Male and female patients >18 years of age
- •Patients who do not have a known allergy to silicon
- •Patients who are able to attend the four post-treatment weekly skin assessment appointments
排除标准
- •Ineligible participants are patients undergoing a course of curative radiation therapy:
- •Who are participating in another interventional study
- •With an allergy to product content (standard or StrataXRT)
- •With an existing skin rash, ulceration or open wound in the treatment area
- •With a pre-existing systemic skin disease (dermatological conditions, connective tissue disorders)
- •Who have had previous radiation therapy to the current treatment area
- •Who are on immuno-suppression drugs
结局指标
主要结局
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
时间窗: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Radiation dermatitis reaction as assessed by blinded assessment of digital photographs using the CTCAE v4.0 radiation dermatitis grades. CTCAE v4.0 severity grades are categorical with 5 possible categories (1, 2, 3, 4, 5). Grade 1 represents the weakest form of radiation dermatitis. Higher CTCAE Grades represent increasing radiation dermatitis severity.
Radiation induced skin reaction assessment scale (RISRAS)
时间窗: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Radiation dermatitis reaction as assessed by the clinician during patient consultations using the eviQ RISRAS form. RISRAS scale is continuous scale from 0 to 36, with higher RISRAS scores representing higher severity of radiation dermatitis.
次要结局
- Length of time until resolution of radiation dermatitis(From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months)
- Cost-effectiveness(From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months)
- Onset of radiation dermatitis(From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months)
- Patient reported symptoms treatment(From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months)
- Incidence of late-effects skin toxicity(3 - 12 months post radiation treatment)