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NCT04317183 Clinical Trial

Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

Oral Mucositis Due to Chemotherapy Clinical Trial

Official title:
The Effect of Topical Chamomile in the Prevention of Chemotherapy-induced Oral Mucositis (a Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04317183
Other study ID # 00010556-IORG 0008839
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 15, 2019
Est. completion date March 30, 2020

Study information
Verified date March 2020
Source Alexandria University
Contact Mahmoud Elhadad, BDS
Phone 01009394469
Email elhadad2008@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 45
Est. completion date March 30, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients who are going to receive 5-Fluoroucil (5-FU) based chemotherapy regime.

Males and females with an age of not less than 20 years and not exceeding 70 years.

Exclusion Criteria:

- 1. Patients suffering from any uncontrolled systemic diseases that affect integrity of the epithelium (such as diabetes, cardiovascular, liver disorder and renal dysfunction) 2. Pregnant and lactating women 3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Egypt Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. — View Citation

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. — View Citation

Ferreira E, Vasques C, Jesus C, Reis P. Topical effects of Chamomilla recutita in skin damage: a literature review. 2015.

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. — View Citation

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.

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. — View Citation

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. Review. — View Citation

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.

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary 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