Clinical trial NCT04317183: Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis
Official title: The Effect of Topical Chamomile in the Prevention of Chemotherapy-induced Oral Mucositis (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Mucositis Due to Chemotherapy
Keywords: oral mucositis, chemotherapy, chamomile.
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in severity of oral mucositis at different time points along the study
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Pain and discomfort severity at different time points along the study: Numeric Rating Scale
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine
Study officials:
affiliation: Alexandria University
name: Ehsan El-Negomy, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Maha Talaab, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Reham Ibrahim, Phd
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Rasha El-Saka
role: STUDY_DIRECTOR
References:
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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. doi: 10.1002/cncr.20162.
citation: 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.