A Randomized, Open-label Study of Coconut Oil Mouth Rinse for Prophylaxis of Severe Oral Mucositis in Pediatric Patients Receiving Myeloablative Conditioning Regimens

  • STATUS
    Recruiting
  • End date
    Aug 20, 2025
  • participants needed
    60
  • sponsor
    Wake Forest University Health Sciences
Updated on 20 October 2022

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. 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.

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

Details
Condition Oral Mucositis
Treatment Virgin Coconut Oil
Clinical Study IdentifierNCT05441813
SponsorWake Forest University Health Sciences
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
As determined by the enrolling physician, 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 as determined by the treating
investigator

Exclusion Criteria

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 SOP, prior to
admission with a plan to continue use during admission
Patient has undergone HSCT within the last 90 days prior to admission
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note