What is the mechanism of action of this treatment?

Common treatments for mouth sores, such as Virgin Coconut Oil (VCO), work primarily through their anti-inflammatory and antimicrobial properties. The anti-inflammatory action helps to reduce swelling, pain, and redness associated with mouth sores, providing relief and promoting healing. The antimicrobial properties help to prevent or reduce infection by targeting harmful bacteria and other pathogens that can exacerbate sores. These mechanisms are crucial for mouth sore patients as they not only alleviate symptoms but also prevent complications, leading to faster recovery and improved oral health.

What side effects are associated with this type of intervention?

Common treatments for mouth sores include saline rinses, diphenhydramine (Benadryl), Mylanta, and lidocaine. Saline rinses are generally safe with minimal side effects. Diphenhydramine can cause drowsiness, dry mouth, and dizziness. Mylanta, an antacid, may lead to gastrointestinal disturbances like diarrhea or constipation. Lidocaine, a local anesthetic, can cause numbness, tingling, and in rare cases, allergic reactions. These treatments aim to reduce inflammation and provide pain relief, similar to the proposed benefits of virgin coconut oil.

What prior FDA approvals exist?

FDA-approved treatments for mouth sores, particularly those with anti-inflammatory and antimicrobial properties, include various mouth rinses and topical agents. Commonly used treatments include normal saline, Benadryl (diphenhydramine), Mylanta, and lidocaine, which help in managing symptoms and preventing infections. While the context does not specify FDA approvals for these treatments, they are widely used in clinical practice for mucositis prevention and treatment. Virgin coconut oil, currently being studied for its potential benefits, shares similar anti-inflammatory and antimicrobial properties.

What other types of research exist?

Promising alternatives to Virgin Coconut Oil for treating mouth sores include: <ol> <li>Topical antiseptics such as povidone-iodine, which have shown effectiveness in treating infections and reducing inflammation.</li> <li></li> </ol> Medical ozone, which has demonstrated benefits in wound healing and antimicrobial activity in small studies. 3. Low-level laser therapy (LLLT), which has been reported to improve healing and reduce symptoms in small retrospective series. 4. Autologous platelet concentrates (APC), which have shown potential in enhancing healing in oral surgery contexts, though evidence quality varies.

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Coconut Oil for Mouth Sores

Phase 2

Recruiting

Led By Courtney Huddle, MSN, RDN, LDN

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Planned discharge home prior to engraftment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 45

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a mouth rinse made from virgin coconut oil can help prevent painful mouth sores in young patients receiving intense treatment. The coconut oil is thought to help by calming and reducing inflammation in the mouth.

Who is the study for?

This trial is for pediatric patients aged 7 to 26 years who are about to receive high-dose chemotherapy and have no current mouth sores. They must be able to perform mouth rinses, not have tree nut allergies, and not be using other non-standard oral care regimens or coconut oil rinses recently.

What is being tested?

The study tests if virgin coconut oil (VCO) can prevent mouth sores when added to standard oral care rinses in children receiving intense chemotherapy. The severity of mouth sores with VCO will be compared against those using only the standard treatment.

What are the potential side effects?

While the side effects aren't detailed here, potential risks may include allergic reactions for those sensitive to coconut products. Generally, VCO is considered safe with minimal risk of adverse effects when used as a rinse.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am preparing for a stem cell transplant with intensive treatment.

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I can care for myself and am up more than 50% of my waking hours.

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I do not have any sores in my mouth.

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I am between 7 and 26 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will be going home before my new cells start to grow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 45

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 45

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 45 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Severity of Mucositis

Secondary study objectives

Average Daily Caloric Intake

Daily Incidence of Optional Mouth Rinses

Days to Absolute Neutrophil Count (ANC) Engraftment

+5 more

Other study objectives

Oral Rinse Utilization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of care + virgin coconut oilExperimental Treatment1 Intervention

Arm A: Standard of care + virgin coconut oil

Group II: Standard of CareActive Control1 Intervention

Arm B: Standard of care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Coconut oil

Not yet FDA approved

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for mouth sores, such as Virgin Coconut Oil (VCO), work primarily through their anti-inflammatory and antimicrobial properties. The anti-inflammatory action helps to reduce swelling, pain, and redness associated with mouth sores, providing relief and promoting healing. The antimicrobial properties help to prevent or reduce infection by targeting harmful bacteria and other pathogens that can exacerbate sores. These mechanisms are crucial for mouth sore patients as they not only alleviate symptoms but also prevent complications, leading to faster recovery and improved oral health.

Oropharyngeal Decontamination with Antiseptics to Prevent Ventilator-Associated Pneumonia: Rethinking the Benefits of Chlorhexidine.A better definition of counselling strategies is needed to define effectiveness in temporomandibular disorders management.Treatment of oral malodour. Medium-term efficacy of mechanical and/or chemical agents: a systematic review.