Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.

February 25, 2019 updated by: Dina Yousef Abdel Aleem Essa, Cairo University

Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy: (A Randomized Pilot Study)

oral mucositis is a painful situation that significantly affects patients' quality of life with the severe cases being associated with ulcerated mucosa and secondary infection which may lead to life-threatening sepsis.Chamomile infusion in cryotherapy was used to aid in reduction of chemotherapy induced mucositis and to enhance the effect of standard cryotherapy alone by its anti-inflammatory, antifungal and antibacterial effect. The occurrence of oral mucositis is a significant complication of chemotherapy with prevalence of up to 80% in pediatric patients.The study is to be conducted at the in and outpatient clinics at the Department of Pediatric Oncology, National Cancer Institute,Egypt. A Structured interview questionnaire sheet will be filled with personal, medical and dental history. Intraoral examination will be carried out using sterile latex gloves, masks, plain mouth mirrors, sterile gauze and wooden tongue depressor. Patients who will agree to participate in the study will watch a video explaining how to perform oral hygiene.Preparation of the interventions is done in the clinic with 400 ml of distilled water with or without the infusion of 10 g of chamomile flowers."Chamomile classic infusion, Royal Herbs" .Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session. Follow ups are done at the 8th,15th and the 21st day of interventions application.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Cairo, Egypt
        • Recruiting
        • National Cancer Institute
        • Contact:
          • Dina Yousef

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with healthy and intact oral mucosa.
  2. Patients diagnosed with bone tumor (osteosarcoma) for the first time.
  3. Patients receiving Methotrexate as part of their chemotherapeutic regimen.
  4. Both male and female patients undergoing chemotherapy at In and Out patient units of Pediatric Oncology department.
  5. Age of patient ranging (6- 18) years old.
  6. Legal representatives of patient must be able to read, understand and provide informed consent to participate in the trial.
  7. Patients with no history of dental discomfort related to cold or hot food or beverage intake.

Exclusion Criteria:

  1. Administration of antiviral or antifungal therapy and/or any other treatment for oral mucositis before enrollment in the study.
  2. Presence of advanced or severe periodontitis (pocket depth more than 6mm).
  3. Patients who were supposed to receive head and neck radiotherapy as part of their treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chamomile oral cryotherapy
  1. The infusion of chamomile will be prepared in the clinic with 400 mL of distilled water and 10 g of chamomile flowers (Chamomile classic infusion, Royal Herbs).
  2. Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.
  3. Patient will receive a cup of ice cubes which is continuously replenished before being emptied.
  4. Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.
The infusion of chamomile will be prepared in the clinic with 400 mL of distilled water and 10 g of chamomile flowers (Chamomile classic infusion, Royal Herbs). Patients are asked to swish the chamomile ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.
Other Names:
  • chamomile oral infusion
Active Comparator: Oral cryotherapy
  1. The plain icecubes will be prepared in the clinic with 400 mL of distilled water.
  2. Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.
  3. Patient will receive a cup of ice cubes which is continuously replenished before being emptied.
  4. Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.
The plain icecubes will be prepared in the clinic with 400 mL of distilled water. Patients are asked to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in "patient-reported oral mucositis".
Time Frame: Assessed at the 8th, 15th and the 21st day after application of the interventions.
Primary outcome is measured using Children International Mucostitis Evaluation Scale (CHIMES).ChIMES1-4 each received a score of 0-5 where 5 is the worst degree of symptoms. ChIMES5 and ChIMES6 received a score of 1 or 0 if the child had received pain medications or not. Finally, ChIMES7 received a score of 1or 0 if oral ulcers were present or not. Any question that was scored as missing or 'I can't tell' was excluded from the total possible score. If all the questions were answered, the maximum score was 23. The ChIMES Total Score was the sum of all scores; 'I can't tell' responses and missing responses both received a score of 0. The ChIMES Percentage Score was the ChIMES Total Score over the total maximum score taking into account 'I can't tell' responses (by subtracting these items from the maximum score) multiplied by 100. Higher values indicate a worse outcome.
Assessed at the 8th, 15th and the 21st day after application of the interventions.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in "Clinical assessment of oral mucositis".
Time Frame: Assessed at the 8th,15th and the 21st day after application of the interventions.
Assessed using Oral Mucositis World Health Organization Toxicity Scale.It represents grades of oral mucositis ranging from 0-4 with higher grades indicating worse outcome.
Assessed at the 8th,15th and the 21st day after application of the interventions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Norhan A Eldokkky, PHD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 21, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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