Oral Mucositis (Ulcerative) Due to Antineoplastic TherapyNCT03605186
Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.
A study testing Chamomile oral cryotherapy and Oral cryotherapy in people with Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
- What is being tested?
- Chamomile oral cryotherapy and Oral cryotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Chamomile oral cryotherapy, Oral cryotherapy
- Keywords
- chamomile cryotherapy, cryotherapy, cancer, children, pediatric, chemotherapy
- Medical subject headings
- Stomatitis, Ulcer, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chamomile oral cryotherapyOther
Also called chamomile oral infusion
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 cryotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chamomile oral cryotherapy | Experimental | 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. Receives: Other: Chamomile oral cryotherapy |
| Oral cryotherapy | Active comparator | 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. Receives: Other: Oral cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at the 8th, 15th and the 21st day after application of the interventions.
Secondary outcomes (1)
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.
Measured: Assessed at the 8th,15th and the 21st day after application of the interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study startFeb 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis (Ulcerative) Due to Antineoplastic TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Egypt
- Responsible party
- Principal investigator, Dina Yousef Abdel Aleem Essa, Cairo University
- Investigators
- Norhan A Eldokkky, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605186
- Sponsor's protocol ID
- CEBD-CU-2018-07-08
- Status last verified
- Feb 2019
- First submitted
- 11 Jul 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy: (A Randomized Pilot Study)
- ClinicalTrials.gov ID
- NCT03605186
- Acronym / sponsor ID
- CEBD-CU-2018-07-08
- Keywords
- chamomile cryotherapy, cryotherapy, cancer, children, pediatric, chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute, Egypt
- Study start
- Feb 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chamomile oral cryotherapy | Experimental | Other: Chamomile oral cryotherapy1. 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. |
| Oral cryotherapy | Active comparator | Other: Oral cryotherapy1. 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chamomile oral cryotherapyAlso: chamomile oral infusionThe 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 | Chamomile oral cryotherapy |
| Oral cryotherapyThe 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. | Other | Oral cryotherapy |
Primary outcome
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.
1 secondary outcome
Change in "Clinical assessment of oral mucositis".
Time frame: Assessed at the 8th,15th and the 21st day after application of the interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norhan A Eldokkky, PHD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chamomile oral cryotherapy and Oral cryotherapy in people with Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Y Essa, B.D.SC (00201008222298, dina.yousef@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in "patient-reported oral mucositis". (time frame: Assessed at the 8th, 15th and the 21st day after application of the interventions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.