Clinical trial NCT03605186: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
Keywords: chamomile cryotherapy
cryotherapy
cancer
children
pediatric
chemotherapy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, Egypt
First posted: 2018-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in "patient-reported oral mucositis".
timeFrame: Assessed at the 8th, 15th and the 21st day after application of the interventions.
Secondary outcomes:
measure: Change in "Clinical assessment of oral mucositis".
timeFrame: Assessed at the 8th,15th and the 21st day after application of the interventions.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: Cairo University
name: Norhan A Eldokkky, PHD
role: STUDY_DIRECTOR
References: