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New treatment option for Oral Mucositis
Official title Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
ClinicalTrials.gov ID: NCT05441813
What this study is testing
What is Virgin Coconut Oil?
Virgin Coconut Oil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for oral mucositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 26
You may be able to join if
- Subject must meet all the following applicable 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...
- 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...
You likely can't join if
- people 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...
- Patient has undergone HSCT within the last 90 days prior to admission
See the full eligibility criteria
- Subject must meet all the following applicable 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlotte, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 26 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlotte, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.