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

NCT ID: NCT03605186

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2020-03-31

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.

Conditions

Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chamomile oral cryotherapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Oral cryotherapy

Intervention Type: OTHER

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.

Interventions

Chamomile oral cryotherapy

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

Oral cryotherapy

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.

Intervention Type: OTHER

Other Intervention Names

chamomile oral infusion

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dina Yousef Abdel Aleem Essa

Master Degree Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norhan A Eldokkky, PHD

Role: STUDY_DIRECTOR

Cairo University

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina Y Essa, B.D.SC

Role: CONTACT

dina.yousef@dentistry.cu.edu.eg

00201008222298

Nada M Wassef, PHD

Role: CONTACT

nadawassef@hotmail.com

+201005074144

Facility Contacts

Dina Yousef

Role: primary

Other Identifiers

CEBD-CU-2018-07-08

Identifier Type: -

Identifier Source: org_study_id