Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis
NCT ID: NCT04317183
Last Updated: 2020-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2019-05-15
2020-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low Level Diode Laser Versus Topical Chamomile in Management of Chemotherapy Induced Oral Mucositis
NCT06214273
Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.
NCT03605186
Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis
NCT01431729
Vitamin D Oral Gel for Prevention of Radiation Induced Oral Mucositis
NCT04308161
Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae
NCT01122147
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All patients have clinically evaluated at the start of the chemotherapy and three weeks later for pain and oral mucositis severity.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chamomile topical gel
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).
chamomile topical oral gel
Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.
conventional therapy
Conventional therapy (symptomatic treatment) which included:
Miconaz oral gel BBC oral spray Oracure gel
Dose: Three times a day for three weeks
Miconazole Topical Gel
topical anti fungal agent
BBC oral spray
Topical anesthetics and anti-inflammatory agent
Oracure gel
Topical analgesic gel
combination therapy
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
chamomile topical oral gel
Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.
Miconazole Topical Gel
topical anti fungal agent
BBC oral spray
Topical anesthetics and anti-inflammatory agent
Oracure gel
Topical analgesic gel
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
chamomile topical oral gel
Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.
Miconazole Topical Gel
topical anti fungal agent
BBC oral spray
Topical anesthetics and anti-inflammatory agent
Oracure gel
Topical analgesic gel
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Males and females with an age of not less than 20 years and not exceeding 70 years.
Exclusion Criteria
20 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hams Hamed Abdelrahman
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hams Hamed Abdelrahman
Assistant lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ehsan El-Negomy, PhD
Role: STUDY_DIRECTOR
Alexandria University
Maha Talaab, PhD
Role: STUDY_DIRECTOR
Alexandria University
Reham Ibrahim, Phd
Role: STUDY_DIRECTOR
Alexandria University
Rasha El-Saka
Role: STUDY_DIRECTOR
Alexandria University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine
Alexandria, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Ferreira E, Vasques C, Jesus C, Reis P. Topical effects of Chamomilla recutita in skin damage: a literature review. 2015.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00010556-IORG 0008839
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.