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the main aim of this study is to clinically assess the effectiveness of topical chamomile oral gel in the prevention of chemotherapy-induced oral mucositis.
The study was designed as a randomized, controlled, clinical trial. patients who were undergoing to receive chemotherapy were divided into three groups: Group I: was given conventional treatment. Group II: was given topical oral gel of chamomile. Group III: was given topical oral gel of chamomile in combination with the conventional treatment.
All patients have clinically evaluated at the start of the chemotherapy and three weeks later for pain and oral mucositis severity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chamomile topical gel | Experimental | Topical oral chamomile gel three times daily for three weeks. Topical oral chamomile gel is prepared with the aid of Pharmacognosy and pharmaceutics departments, faculty of pharmacy, Alexandria University and mucoadhesive hydrogels (Carbopol® 970). |
|
| conventional therapy | Active Comparator | Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks |
|
| combination therapy | Experimental | Topical oral chamomile gel three times daily for three weeks in combination with the symptomatic treatment Symptomatic treatment which included: Miconaz oral gel BBC oral spray Oracure gel Symptomatic treatment dose: Three times a day for three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chamomile topical oral gel | Drug | Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in severity of oral mucositis at different time points along the study | Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third week after the first chemotherapy session. | Up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and discomfort severity at different time points along the study: Numeric Rating Scale | Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the first , second and third week after the chemotherapy session. | Up to 3 weeks |
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Inclusion Criteria:
Males and females with an age of not less than 20 years and not exceeding 70 years.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Elhadad, BDS | Contact | 01009394469 | elhadad2008@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ehsan El-Negomy, PhD | Alexandria University | Study Director |
| Maha Talaab, PhD | Alexandria University | Study Director |
| Reham Ibrahim, Phd |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine | Recruiting | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Presibella MM, Villas-Bôas LDB, Belletti KMdS, Santos CAdM, Weffort-Santos AM. Comparison of chemical constituents of Chamomilla recutita (L.) Rauschert essential oil and its anti-chemotactic activity. Brazilian archives of biology and technology. 2006;49(5):717-24. | ||
| Background | Ferreira E, Vasques C, Jesus C, Reis P. Topical effects of Chamomilla recutita in skin damage: a literature review. 2015. | ||
| Background | Tadbir AA, Pourshahidi S, Ebrahimi H, Hajipour Z, Memarzade MR, Shirazian SJJoHM. The effect of Matricaria chamomilla (chamomile) extract in Orabase on minor aphthous stomatitis, a randomized clinical trial. 2015;5(2):71-6. | ||
| 8630960 | Background | Fidler P, Loprinzi CL, O'Fallon JR, Leitch JM, Lee JK, Hayes DL, Novotny P, Clemens-Schutjer D, Bartel J, Michalak JC. Prospective evaluation of a chamomile mouthwash for prevention of 5-FU-induced oral mucositis. Cancer. 1996 Feb 1;77(3):522-5. doi: 10.1002/(SICI)1097-0142(19960201)77:33.0.CO;2-6. |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Miconazole Topical Gel | Drug | topical anti fungal agent |
|
| BBC oral spray | Drug | Topical anesthetics and anti-inflammatory agent |
|
| Oracure gel | Drug | Topical analgesic gel |
|
| Alexandria University |
| Study Director |
| Rasha El-Saka | Alexandria University | Study Director |
| 25232958 | Background | Braga FT, Santos AC, Bueno PC, Silveira RC, Santos CB, Bastos JK, Carvalho EC. Use of Chamomilla recutita in the Prevention and Treatment of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized, Controlled, Phase II Clinical Trial. Cancer Nurs. 2015 Jul-Aug;38(4):322-9. doi: 10.1097/NCC.0000000000000194. |
| 16173332 | Background | Baydar M, Dikilitas M, Sevinc A, Aydogdu I. Prevention of oral mucositis due to 5-fluorouracil treatment with oral cryotherapy. J Natl Med Assoc. 2005 Aug;97(8):1161-4. |
| 15108222 | Background | Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162. |
| 15108223 | Background | Rubenstein EB, Peterson DE, Schubert M, Keefe D, McGuire D, Epstein J, Elting LS, Fox PC, Cooksley C, Sonis ST; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer. 2004 May 1;100(9 Suppl):2026-46. doi: 10.1002/cncr.20163. |