Topical Boswellia Serrata 2% to Prevent Radiation Dermatitis in Head and Neck Cancer
Topical Boswellia Serrata Roxb. Gum Resin 2% Cream for the Prevention of Radiation-Induced Dermatitis in Head and Neck Cancer Patients
研究概览
详细说明
Background: Acute radiation-induced dermatitis is a common adverse effect in patients undergoing radiotherapy for head and neck cancer, and it can impair quality of life and, when severe, contribute to treatment interruptions. Boswellia serrata gum resin (Indian olibanum) has recognized anti-inflammatory properties, and a topical boswellic-acid cream previously reduced skin-reaction severity and the need for rescue corticosteroids in breast radiotherapy. Evidence in head and neck cancer is lacking.
Objective: To evaluate the efficacy of a 2% Boswellia serrata gum-resin topical cream in preventing or reducing acute radiation-induced dermatitis in head and neck cancer patients undergoing radiotherapy.
Design: Non-randomized (quasi-experimental), open-label, interventional study with two parallel groups. The intervention group applies the 2% Boswellia cream to the radiation field twice daily throughout radiotherapy; the control group receives no preventive topical treatment (rescue treatment only if skin reactions occur). Planned enrollment is 60 participants (about 30 per group), based on an a priori power analysis for the difference in rescue-treatment requirement between groups.
Setting: Alexandria University Main Hospitals and Ayady Almostakbal Hospital, Egypt.
Assessments: Skin toxicity is graded at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 2 and 4 weeks after radiotherapy, using both the RTOG acute radiation morbidity skin score and CTCAE v5.0. Patient-reported pain, itching, and burning (numeric rating scales) and a skin-related quality-of-life instrument are collected. Rescue interventions, adverse events, and radiotherapy interruptions are logged.
Ethics: The study was approved by the Research Ethics Committee, Faculty of Medicine, Alexandria University (serial 0109668; IRB 00012098; FWA 00018699). Written informed consent is obtained from every participant before enrollment.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Youssef Hashem Hafez
- 电话号码：+20 110 007 9619
- 邮箱：youssefhashem17@gmail.com
学习地点
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Alexandria、埃及
- 招聘中
- Alexandria university main hospitals
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Alexandria、埃及
- 招聘中
- Ayady Almostakbal Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
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Inclusion Criteria:
- Adults aged 18 years or older, of any sex, with histologically confirmed head and neck cancer for which radiotherapy is indicated
- Planned external-beam radiotherapy to the head and neck region (curative or adjuvant intent) with a planned total dose of at least 60 Gy; concurrent chemotherapy is permitted
- Able to provide written informed consent and comply with the protocol (twice-daily cream application, follow-up visits, and a skin diary)
- Agreement to avoid other topical treatments in the radiation field during the study period (except study-provided or allowed rescue medication)
Exclusion Criteria:
- Previous radiotherapy to the same site
- Previous extensive surgery or reconstruction in the head and neck region that substantially alters the radiation field or interferes with skin assessment
- Known allergy or hypersensitivity to Boswellia serrata, boswellic acids, or any component of the cream base
- Current use of systemic corticosteroids or anti-inflammatory medications that could influence skin reactions (low-dose corticosteroids as chemotherapy premedication are allowed)
- Dermatologic conditions in the treatment area that could interfere with assessment (e.g., psoriasis, scleroderma, severe acne, chronic wounds)
- Pre-existing dermatitis or significant skin lesions in the radiation field at baseline
- Pregnancy or breastfeeding
- Any other condition that, in the investigator's judgment, would compromise participation or confound the results
Exclusion Criteria:
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学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Boswellia 2% Cream
Topical Boswellia serrata 2% gum-resin cream applied to the radiation field twice daily throughout the radiotherapy course.
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A cream containing 2% Boswellia serrata (Indian olibanum) gum resin, applied to the radiation field twice daily throughout the radiotherapy course.
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无干预：Control (No Preventive Treatment)
No preventive topical treatment during radiotherapy; usual care, with rescue treatment provided only if skin reactions occur.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rescue treatment requirement
大体时间：From start of radiotherapy through 4 weeks after completion of radiotherapy (up to approximately 11 weeks)
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Proportion of participants who require any rescue medication beyond the study cream to manage skin reactions (most importantly topical corticosteroids, but also oral analgesics, antibiotics, or wound care).
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From start of radiotherapy through 4 weeks after completion of radiotherapy (up to approximately 11 weeks)
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Improvement in skin condition (change-of-condition assessment)
大体时间：At the end of radiotherapy (approximately 7 weeks)
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Proportion of participants whose skin condition is rated 'improved' or 'in remission' versus 'unchanged' or 'worsened' on a standardized change-of-condition assessment (adapted from psoriasis/eczema studies) at the end of radiotherapy.
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At the end of radiotherapy (approximately 7 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to onset of radiodermatitis
大体时间：From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
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Time (days) from the start of radiotherapy to the first occurrence of a grade 1 or higher skin reaction (RTOG/CTCAE).
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From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
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Maximum severity of radiodermatitis
大体时间：From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
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Highest radiodermatitis grade recorded during the study, assessed using the RTOG acute radiation morbidity skin score and CTCAE v5.0.
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From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
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Patient-reported skin symptoms
大体时间：Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
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Weekly patient-reported pain, itching, and burning of the treated skin, each rated on a 0-10 numeric rating scale.
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Weekly, from start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
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Radiotherapy interruptions due to skin toxicity
大体时间：During radiotherapy (approximately 7 weeks)
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Number and duration (days) of radiotherapy interruptions or missed fractions attributable to skin toxicity.
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During radiotherapy (approximately 7 weeks)
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Incidence of adverse events (safety and tolerability)
大体时间：From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
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Incidence of local and systemic adverse events, including allergic contact dermatitis, associated with daily application of the study cream.
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From start of radiotherapy through 4 weeks after completion (up to approximately 11 weeks)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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