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

Primary Purpose

Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Chamomile oral cryotherapy
Oral cryotherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy focused on measuring chamomile cryotherapy, cryotherapy, cancer, children, pediatric, chemotherapy

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chamomile oral cryotherapy

Oral cryotherapy

Arm Description

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). Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose. Patient will receive a cup of ice cubes which is continuously replenished before being emptied. 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. Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose. Patient will receive a cup of ice cubes which is continuously replenished before being emptied. 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.

Outcomes

Primary Outcome Measures

Change in "patient-reported oral mucositis".
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.

Secondary Outcome Measures

Change in "Clinical assessment of oral mucositis".
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.

Full Information

First Posted
July 11, 2018
Last Updated
February 25, 2019
Sponsor
Cairo University
Collaborators
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT03605186
Brief Title
Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.
Official Title
Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy: (A Randomized Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
Keywords
chamomile cryotherapy, cryotherapy, cancer, children, pediatric, chemotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chamomile oral cryotherapy
Arm Type
Experimental
Arm Description
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). Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose. Patient will receive a cup of ice cubes which is continuously replenished before being emptied. 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.
Arm Title
Oral cryotherapy
Arm Type
Active Comparator
Arm Description
The plain icecubes will be prepared in the clinic with 400 mL of distilled water. Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose. Patient will receive a cup of ice cubes which is continuously replenished before being emptied. 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.
Intervention Type
Other
Intervention Name(s)
Chamomile oral cryotherapy
Other Intervention Name(s)
chamomile oral infusion
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oral cryotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in "patient-reported oral mucositis".
Description
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.
Time Frame
Assessed at the 8th, 15th and the 21st day after application of the interventions.
Secondary Outcome Measure Information:
Title
Change in "Clinical assessment of oral mucositis".
Description
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.
Time Frame
Assessed at the 8th,15th and the 21st day after application of the interventions.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with healthy and intact oral mucosa. Patients diagnosed with bone tumor (osteosarcoma) for the first time. Patients receiving Methotrexate as part of their chemotherapeutic regimen. Both male and female patients undergoing chemotherapy at In and Out patient units of Pediatric Oncology department. Age of patient ranging (6- 18) years old. Legal representatives of patient must be able to read, understand and provide informed consent to participate in the trial. Patients with no history of dental discomfort related to cold or hot food or beverage intake. Exclusion Criteria: Administration of antiviral or antifungal therapy and/or any other treatment for oral mucositis before enrollment in the study. Presence of advanced or severe periodontitis (pocket depth more than 6mm). Patients who were supposed to receive head and neck radiotherapy as part of their treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Y Essa, B.D.SC
Phone
00201008222298
Email
dina.yousef@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Nada M Wassef, PHD
Phone
+201005074144
Email
nadawassef@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norhan A Eldokkky, PHD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Yousef

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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