NCT04317183

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

March 19, 2020

Last Update Submit

March 19, 2020

Conditions

Oral Mucositis Due to Chemotherapy

Keywords

oral mucositis, chemotherapy, chamomile.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Up to 3 weeks

Study Arms (3)

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).

Drug: chamomile topical oral gel

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

Drug: Miconazole Topical GelDrug: BBC oral sprayDrug: Oracure gel

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

Drug: chamomile topical oral gelDrug: Miconazole Topical GelDrug: BBC oral sprayDrug: Oracure gel

Interventions

chamomile topical oral gelDRUG

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

Chamomile topical gelcombination therapy
Miconazole Topical GelDRUG

topical anti fungal agent

combination therapyconventional therapy
BBC oral sprayDRUG

Topical anesthetics and anti-inflammatory agent

combination therapyconventional therapy
Oracure gelDRUG

Topical analgesic gel

combination therapyconventional therapy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine

Alexandria, Egypt

RECRUITING

Related Publications (8)

  • 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.

    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.

    PMID: 8630960BACKGROUND

  • 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.

    PMID: 25232958BACKGROUND

  • 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.

    PMID: 16173332BACKGROUND

  • 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.

    PMID: 15108222BACKGROUND

  • 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.

    PMID: 15108223BACKGROUND

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Ehsan El-Negomy, PhD

    Alexandria University

    STUDY DIRECTOR

  • Maha Talaab, PhD

    Alexandria University

    STUDY DIRECTOR

  • Reham Ibrahim, Phd

    Alexandria University

    STUDY DIRECTOR

  • Rasha El-Saka

    Alexandria University

    STUDY DIRECTOR

Central Study Contacts

Mahmoud Elhadad, BDS

CONTACT

01009394469elhadad2008@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

May 15, 2019

Primary Completion

March 15, 2020

Study Completion

March 30, 2020

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)