Oral MucositisPhase 2NCT05441813
Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
A Phase 2 study testing Virgin Coconut Oil in people with Oral Mucositis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. Read more about this study
- Who is it for?
- Ages 7 to 26 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Virgin Coconut Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to Jul 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 7 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject must meet all the following applicable inclusion criteria to participate in this study:
- Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
- Age greater than or equal to 7 years to 26 years at the time of consent
- Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT
- ECOG Performance Status of less than or equal to 2 or Lansky/Karnofsky Performance Status of greater than or equal to 50 within 7 days prior to date of enrollment.
- No evidence of mouth lesions at time of enrollment
- Ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study
- Able and willing to swish/spit the oral formulation
Who cannot join
- Subjects meeting any of the criteria below may not participate in the study:
- Allergy to tree nuts
- Planned discharge home prior to engraftment
- Using coconut oil mouth rinses within 30 days prior to enrollment
- Using additional mouthcare regimens, other than those allowed in the institutional SOP, prior to admission with a plan to continue use during admission
- Patient has undergone HSCT within the last 90 days prior to admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Levine Children's Hospital
Charlotte, North Carolina, 28203
Courtney Huddle, DCN, RDN, CSPCC, LDN
About this study
Official title: A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens
The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. The severity of oral mucositis between the 2 groups will be evaluated. Some of the standard of care rinses that can be used to prevent mucositis are normal saline, Benadryl (diphenhydramine), Mylanta, lidocaine, or other combinations.
Read the detailed description
This is a randomized, open-label study. The target population is patients ≥ 7 years to 26 years at time of consent who are planning to undergo myeloablative conditioning regimens in preparation HSCT. The study will be conducted at Levine Children's Hospital, Levine Children's Cancer and Blood Disorders Clinic and Atrium Health. Subjects will be screened and consented within 28 days prior to admission. The planned treatment period for Arm A (standard of care with the addition of VCO mouth rinses) or Arm B (standard of care) will begin at the start of subject's admission for conditioning, followed by transplant event with day of transplant defined as Day 0 and continue through Day +45 following transplant or hospital discharge, whichever comes first. A Safety Follow Up Visit will occur no sooner than 30 days from last study drug treatment
- Conditions
- Oral Mucositis
- Being tested
- Virgin Coconut Oil
- Keywords
- Prevention, Virgin Coconut Oil, Mouth Rinse
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virgin Coconut OilDrug
Standard of care with the addition of virgin coconut oil mouth rinse
| Study group | Role | What they receive |
|---|---|---|
| Standard of care + virgin coconut oil | Experimental | Arm A: Standard of care + virgin coconut oil Receives: Drug: Virgin Coconut Oil |
| Standard of Care | No intervention | Arm B: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Mucositis
Using Area Under the Curve (AUC) of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 mucositis oral grading scale. This is a 5-point ordered-categorical scale ranging from 1 (asymptomatic or mild symptoms) to 5 (death). For subjects not experiencing oral mucositis, a severity grade of zero will be assigned.
Measured: Day 45
Secondary outcomes (8)
Average Daily Caloric Intake
Oral intake will be calculated quantitatively for each subject during the on-treatment period.
Measured: Day 45
Total Parenteral Nutrition (TPN)
TPN or hyperalimentation will be calculated quantitatively for each subject as the proportion of days during the on-treatment period that aggressive nutrition support was utilized.
Measured: Day 45
Opioid Use
Daily opioid use will be calculated quantitatively for each subject in terms of their average Morphine Equivalent Daily Dose (MEDD)
Measured: Day 45
Time to CTCAE Mucositis Grade > 2
The duration of time (in days) from the initiation of study treatment until the day of the first occurrence of a CTCAE mucositis grade exceeding 2. The CTCAE mucositis grade is a 5-point ordered-categorical scale ranging from 1 (asymptomatic or mild symptoms) to 5 (death). For subjects who do not report a grade exceeding 2, time to CTCAE mucositis grade >2 will be censored at the date of the last completed CTCAE evaluation.
Measured: Day 45
Daily Incidence of Optional Mouth Rinses
Proportion of days during the on-treatment period that optional oral rinse was used.
Measured: Day 45
Incidence and type of oral viral infections
Incidence and type of oral viral infections
Measured: Day 45
Length of Hospitalization
Length of stay will be calculated for each subject as the number of days from admission date to discharge date +1.
Measured: Day 45
Days to Absolute Neutrophil Count (ANC) Engraftment
Days to engraftment will be calculated for each subject as the number of days from Hematopoietic Stem Cell Transplantation (HSCT) to ANC recovery per Center for International Blood and Marrow Transplantation Research (CIBMTR) definition
Measured: Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start15 Feb 2023
- Primary completionJul 2036 (estimated)
- Study completionJul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney Huddle, DCN, RDN, CSPCC, LDN, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441813
- Sponsor's protocol ID
- LCI-PED-BMT-MUC-001
- Other IDs
- Pro00061628, NCI-2024-06522
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens
- ClinicalTrials.gov ID
- NCT05441813
- Acronym / sponsor ID
- LCI-PED-BMT-MUC-001
- Conditions
- Oral Mucositis
- Keywords
- Prevention, Virgin Coconut Oil, Mouth Rinse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- Jul 2036 (estimated)
- Study completion
- Jul 2036 (estimated)
- First posted
- 1 Jul 2022 (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.
The purpose of this study is to learn if virgin coconut oil (VCO) mouth rinse can help prevent oral mucositis. The Study Investigator will compare standard of care mucositis prevention rinses with the VCO mouth rinse added to the standard of care mucositis prevention rinses. The severity of oral mucositis between the 2 groups will be evaluated. Some of the standard of care rinses that can be used to prevent mucositis are normal saline, Benadryl (diphenhydramine), Mylanta, lidocaine, or other combinations.
Detailed description
This is a randomized, open-label study. The target population is patients ≥ 7 years to 26 years at time of consent who are planning to undergo myeloablative conditioning regimens in preparation HSCT. The study will be conducted at Levine Children's Hospital, Levine Children's Cancer and Blood Disorders Clinic and Atrium Health. Subjects will be screened and consented within 28 days prior to admission. The planned treatment period for Arm A (standard of care with the addition of VCO mouth rinses) or Arm B (standard of care) will begin at the start of subject's admission for conditioning, followed by transplant event with day of transplant defined as Day 0 and continue through Day +45 following transplant or hospital discharge, whichever comes first. A Safety Follow Up Visit will occur no sooner than 30 days from last study drug treatment
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care + virgin coconut oil | Experimental | Drug: Virgin Coconut OilArm A: Standard of care + virgin coconut oil |
| Standard of Care | No intervention | –Arm B: Standard of care |
Who may qualify
- Ages
- 7 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Subject must meet all the following applicable inclusion criteria to participate in this study:
- Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
- Age greater than or equal to 7 years to 26 years at the time of consent
- Patients planning to undergo myeloablative conditioning regimens in preparation for HSCT
- ECOG Performance Status of less than or equal to 2 or Lansky/Karnofsky Performance Status of greater than or equal to 50 within 7 days prior to date of enrollment.
Key exclusion criteria (6 listed)
- Allergy to tree nuts
- Planned discharge home prior to engraftment
- Using coconut oil mouth rinses within 30 days prior to enrollment
- Using additional mouthcare regimens, other than those allowed in the institutional SOP, prior to admission with a plan to continue use during admission
- Patient has undergone HSCT within the last 90 days prior to admission
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 |
|---|---|---|
| Virgin Coconut OilStandard of care with the addition of virgin coconut oil mouth rinse | Drug | Standard of care + virgin coconut oil |
Primary outcome
Severity of Mucositis
Time frame: Day 45
Using Area Under the Curve (AUC) of the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 mucositis oral grading scale. This is a 5-point ordered-categorical scale ranging from 1 (asymptomatic or mild symptoms) to 5 (death). For subjects not experiencing oral mucositis, a severity grade of zero will be assigned.
8 secondary outcomes
Average Daily Caloric Intake
Time frame: Day 45
Total Parenteral Nutrition (TPN)
Time frame: Day 45
Opioid Use
Time frame: Day 45
Time to CTCAE Mucositis Grade > 2
Time frame: Day 45
Daily Incidence of Optional Mouth Rinses
Time frame: Day 45
Incidence and type of oral viral infections
Time frame: Day 45
Length of Hospitalization
Time frame: Day 45
Days to Absolute Neutrophil Count (ANC) Engraftment
Time frame: Day 45
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Courtney Huddle, DCN, RDN, CSPCC, LDN principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virgin Coconut Oil in people with Oral Mucositis, run by Wake Forest University Health Sciences at 1 site in United States.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sceria Jenkins, RN (980-442-2323, sceria.jenkins@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Mucositis (time frame: Day 45). 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 22 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.