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| 005 | 20260420203326.0 | ||
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| 082 | 0 | 4 | _a616.99449 |
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| 097 | _aM.Sc | ||
| 099 | _aCai01.08.08.Ph.D.2025.Is.C | ||
| 100 | 0 |
_aIsraa Kamal Mohamed, _epreparation. |
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| 245 | 1 | 2 |
_aA comparative study between the use of topical betamethasone cream or topical olive oil cream as prophylactic agents in reducing acute radiodermatitis in breast cancer patients / _cby Israa Kamal Mohamed ; Supervision Prof. Dr. Samar F. Farid, Prof. Dr. Maggie M. Abbassi, Prof. Dr. Mohamed R. Kelany. |
| 246 | 1 | 5 | _aدراسة مقارنة بين استخدام كريم بيتاميثازون الموضعي أو كريم زيت الزيتون الموضعي كعوامل وقائية في الحد من التهاب الجلد الإشعاعي الحاد لدى مرضى سرطان الثدي |
| 264 | 0 | _c2025. | |
| 300 |
_a138 pages : _billustrations ; _c25 cm. + _eCD. |
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| 336 |
_atext _2rda content |
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_aUnmediated _2rdamedia |
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_avolume _2rdacarrier |
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| 502 | _aThesis (Ph.D)-Cairo University, 2025. | ||
| 504 | _aBibliography: pages 92-111. | ||
| 520 | 3 | _aPurpose: Breast cancer is the most common malignancy among Egyptian women and represents a major public health concern. Recent estimates indicate that breast cancer accounts for approximately 32–39% of all female cancers in Egypt. Radiotherapy is a cornerstone of breast cancer management as it is commonly used after both breast-conserving surgery and mastectomy, depending on tumor characteristics and patient risk factors. Skin is the first organ exposed to radiation, leading to the most common side effect, acute radiation-induced dermatitis (RID), which is a complex process involving direct cellular damage, oxidative stress, and multiple inflammatory responses. This study aims to compare topical betamethasone-17-valerate and olive oil cream in preventing (RID) in breast cancer patients, to provide prospective data evaluating the quality of life, subjective symptoms, and treatment satisfaction reported by the patients, and to translate and validate the Functional Assessment of Chronic Illness Therapy – General Treatment Satisfaction (FACIT-TS-G) questionnaire into Arabic for use in the study population. Methods: This was a prospective, double-blind, randomized, parallel, placebo-controlled trial. A total of 132 patients were randomized into three groups to receive either olive oil cream (G1), betamethasone-17-valerate (Betnovate® cream, GlaxoSmithKline) (G2), or unmedicated cream base (G3) throughout radiotherapy (RT) and 2 weeks after. The study is registered on clinicaltrials.gov with ID: NCT05285943, Date: November 2021. Results: A total of 128 patients were included in the final analysis. Regarding the proportions of patients developing different Radiation Therapy Oncology Group (RTOG) grades, betamethasone and olive oil significantly differed from the unmedicated cream base at weeks 1 – 4 (P <0.05). At week 5, only significance was observed between olive oil and unmedicated cream base (P =0.013), and the mean RTOG grades was significantly lower in olive oil and betamethasone groups than in the unmedicated cream base group (P < 0.05 at weeks 1 – 5) but, there was no significant difference between olive oil and betamethasone (P>0.999). Furthermore, the percentage of patients who developed grade 3 at the end of the follow-up was significantly different between the olive oil group and the unmedicated cream base group (27.9 % vs 61%, p = 0.004). Additionally, olive oil and betamethasone had non-significant delayed grade 2 and grade 3 development (P >0.999). Differences in Dermatology Life Quality Index (DLQI) scores or summed Visual Analog Scale (VAS) between the olive oil and unmedicated cream base groups, as well as the betamethasone and unmedicated cream base groups, were statistically significant (P< 0.001). However, the difference between the olive oil and betamethasone groups was not statistically significant (P> 0.999). There was a non-significant time and group interaction for both the DLQI scores (p = 0.848) and the summed VAS scores (p = 0.11), indicating that the changes in these outcomes over time were consistent across different times and an overall reduction in the patients' DLQI score and summed VAS score mean, regardless of the topical treatment received. Conclusion: Although neither intervention demonstrated prophylactic efficacy, olive oil cream is as effective as betamethasone in mitigating radiodermatitis severity, delaying the onset of radiodermatitis, reducing the incidence of grade 3 dermatitis, and preventing treatment interruptions compared to unmedicated base cream in patients treated with adjuvant radiotherapy for breast cancer. FACIT-TS-G version 4 is now validated in Arabic and approved by FACIT and can be used in clinical trials with permission (www.facit.org). | |
| 520 | 3 | _aالهدف: الغرض من هذه الدراسة هو مقارنة كريم بيتاميثازون-17-فاليريت الموضعي وزيت الزيتون في الوقاية من التهاب الجلد الناجم عن الإشعاع (RID) لدى مريضات سرطان الثدي وتوفير بيانات مستقبلية لتقييم نوعية الحياة والأعراض الذاتية ورضا العلاج الذي أبلغ عنه المرضى. المرضى و الطرق المستخدمة: كانت هذه دراسة مستقبلية، مزدوجة التعمية، عشوائية، موازية، مضبوطة بعلاج وهمي. تم تززيع 132 مريضة عشوائيًا إلى ثلاث مجموعات لتلقي إما كريم زيت الزيتون (G1)، أو بيتاميثازون-17-فاليريت (كريم بيتنوفيت®، جلاكسو سميث كلاين) (G2)، أو قاعدة كريم غير معالج (G3) طوال فترة العلاج الإشعاعي (RT) وبعده بأسبوعين. سُجِّلت الدراسة على موقع clinicaltrials.gov برقم تعريف: NCT05285943، بتاريخ: نوفمبر 2021. النتائج: تم تضمين 128 مريضة في التحليل النهائي. اختلف بيتاميثازون وزيت الزيتون اختلافًا كبيرًا عن قاعدة كريم غير معالج في الأسابيع 1-4 (P<0.05). في الأسبوع 5، لوحظ وجود دلالة إحصائية فقط بين زيت الزيتون وقاعدة كريم غير معالج (P = 0.013)، وكان متوسط درجةRTOG (مجموعة العلاج الإشعاعي لسرطان للأورام) أقل بكثير في مجموعتي زيت الزيتون وبيتاميثازون مقارنةً بالمجموعة الأخرى (P<0.05 في الأسابيع 1-5)، ولكن لم يكن هناك فرق كبير بين زيت الزيتون وبيتاميثازون (P> 0.999). علاوة على ذلك، كانت نسبة المرضى الذين أصيبوا بالدرجة الثالثة في نهاية المتابعة مختلفة بشكل كبير بين مجموعة زيت الزيتون وقاعدة كريم غير معالج (27.9% مقابل 61%، P = 0.004). بالإضافة إلى ذلك، أظهر زيت الزيتون وبيتاميثازون تأخيرًا غير ذي دلالة إحصائية في تطور الدرجتين الثانية والثالثة (P > 0.999). الاستنتاج: كريم زيت الزيتون بنفس فعالية بيتاميثازون في تخفيف أعراض الـ RID لدى المريضات اللاتي خضعن للعلاج الإشعاعي المساعد لسرطان الثدي. | |
| 530 | _aIssues also as CD. | ||
| 546 | _aText in English and abstract in Arabic & English. | ||
| 650 | 0 | _aBreast Cancer | |
| 650 | 0 | _aسرطان الثدي | |
| 653 | 1 |
_aBreast cancer _aRadiotherapy _aAcute radiation-induced dermatitis _aBetamethasone _aOlive oil _aPatient-reported outcomes _aسرطان الثدي _aالعلاج الإشعاعي |
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| 700 | 0 |
_aSamar F. Farid _ethesis advisor. |
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| 700 | 0 |
_aMaggie M. Abbassi _ethesis advisor. |
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| 700 | 0 |
_aMohamed R. Kelany _ethesis advisor. |
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| 900 |
_b01-01-2025 _cSamar F. Farid _cMaggie M. Abbassi _cMohamed R. Kelany _UCairo University _FFaculty of Pharmacy _DDepartment of Clinical Pharmacy |
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| 905 | _aShimaa | ||
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_2ddc _cTH _e21 _n0 |
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| 999 | _c179626 | ||