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Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

Primary Purpose

Oral Mucositis Due to Chemotherapy

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

chamomile topical oral gel

Miconazole Topical Gel

BBC oral spray

Oracure gel

About this trial

This is an interventional prevention trial for Oral Mucositis Due to Chemotherapy focused on measuring oral mucositis, chemotherapy, chamomile.

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outpatient clinic of Department of Clinical Oncology, Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Chamomile topical gel

conventional therapy

combination therapy

Arm Description

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 (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04317183

First Posted

March 19, 2020

Last Updated

March 19, 2020

Sponsor

Hams Hamed Abdelrahman

1. Study Identification

Unique Protocol Identification Number

NCT04317183

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2019 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Mucositis Due to Chemotherapy

Keywords

oral mucositis, chemotherapy, chamomile.

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chamomile topical gel

Arm Type

Experimental

Arm Description

Arm Title

conventional therapy

Arm Type

Active Comparator

Arm Description

Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Dose: Three times a day for three weeks

Arm Title

combination therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

chamomile topical oral gel

Intervention Description

Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.

Intervention Type

Drug

Intervention Name(s)

Miconazole Topical Gel

Intervention Description

topical anti fungal agent

Intervention Type

Drug

Intervention Name(s)

BBC oral spray

Intervention Description

Topical anesthetics and anti-inflammatory agent

Intervention Type

Drug

Intervention Name(s)

Oracure gel

Intervention Description

Topical analgesic gel

Primary Outcome Measure Information:

Title

Changes in severity of oral mucositis at different time points along the study

Description

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.

Time Frame

Up to 3 weeks

Secondary Outcome Measure Information:

Title

Pain and discomfort severity at different time points along the study: Numeric Rating Scale

Description

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.

Time Frame

Up to 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mahmoud Elhadad, BDS

Phone

01009394469

elhadad2008@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ehsan El-Negomy, PhD

Organizational Affiliation

Alexandria University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Maha Talaab, PhD

Organizational Affiliation

Alexandria University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Reham Ibrahim, Phd

Organizational Affiliation

Alexandria University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rasha El-Saka

Organizational Affiliation

Alexandria University

Official's Role

Study Director

Facility Information:

Facility Name

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine

City

Alexandria

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahmoud Elhadad

Phone

01009394469

elhadad2008@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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.

Results Reference

background

Citation

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

Results Reference

background

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.

Results Reference

background

PubMed Identifier

8630960

Citation

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.

Results Reference

background

PubMed Identifier

25232958

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.

Results Reference

background

PubMed Identifier

16173332

Citation

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.

Results Reference

background

PubMed Identifier

15108222

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.

Results Reference

background

PubMed Identifier

15108223

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.

Results Reference

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Topical Chamomile in Preventing Chemotherapy-induced Oral Mucositis

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