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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Youssef Hashem Hafez
- 電話番号：+20 110 007 9619
- メール：youssefhashem17@gmail.com
研究場所
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Alexandria、エジプト
- 募集
- Alexandria university main hospitals
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Alexandria、エジプト
- 募集
- Ayady Almostakbal Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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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研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rescue treatment requirement
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to onset of radiodermatitis
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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