Dexamethasone for Stomatitis

Phase-Based Estimates
2
Effectiveness
3
Safety
Saint John Macomb-Oakland Hospital, Warren, MI
Stomatitis+2 More
Dexamethasone - Drug
Eligibility
18+
All Sexes
Eligible conditions
Stomatitis

Study Summary

This study is evaluating whether dexamethasone can help reduce the side effects of everolimus.

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Eligible Conditions

  • Stomatitis
  • Cancer
  • Neoplasms
  • Neoplasms, Malignant

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Dexamethasone will improve 2 primary outcomes and 15 secondary outcomes in patients with Stomatitis. Measurement will happen over the course of Up to 8 weeks.

Up to 2 months
Proportion of patients who experience grade 2 stomatitis
Up to 8 weeks
Adherence to everolimus therapy dose
Dexamethasone prescription fill rates
Incidence of grade > 2 mIAS as measured by the SWISH trial
Incidence of mouth pain
Incidence of patients reducing everolimus dose
Incidence of patients stopping everolimus early
Incidence rate of the mTOR inhibitor-associated stomatitis (mIAS)-related pain based on daily self-reports via the numerical analogue scale
Mean and median degrees of patient-reported mouth sores per study arm assessed by NAMPS
Median degree of patient-reported mouth sores per study arm assessed by NAMPS
Mouth/throat sore level of activity interference with daily activities
Quality of life assessed by Linear Analogue Self-Assessment
Severity of mouth pain scores
Sleep level of activity interference with daily activities
Time to develop mouth sores per study arm assessed by PRO-CTCAE Mouth/throat sore item regarding severity
Time to development of mouth pain
Time to dexamethasone prescription fill

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Group II (placebo)
Group I (dexamethasone)
Placebo group

This trial requires 39 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dexamethasone is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Group I (dexamethasone)Patients receive 10mg oral everolimus daily as standard of care and 10ml dexamethasone oral mouthwash, swished for 2-minutes daily, for 8 weeks.
Group II (placebo)Patients receive 10mg oral everolimus daily as standard of care and 10ml placebo oral mouthwash, swished for 2-minutes daily, for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 months for reporting.

Closest Location

Saint John Macomb-Oakland Hospital - Warren, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has not received chemotherapy or any other agent that is known to cause mucositis or stomatitis show original
There has been no history of candida infection (thrush) in the last 3 months. show original
The person is not being treated with corticosteroids at the moment. show original
The patient is currently being diagnosed with cancer and will be taking oral everolimus 10 mg/day with or without an endocrine agent show original
If you have any prior chemotherapy or other stomatitis/mucositis-causing therapy, it must be completed at least 2 weeks prior to registration. show original
The patient should not currently have any stomatitis or mucositis, and should not have had any mouth pain in the past seven days. show original
No other medications should be taken to treat stomatitis or mouth ulcers, as this could interfere with the results of the study. show original
Unless you have uncontrolled diabetes mellitus, defined as hemoglobin A1C greater than 8%, you will need to have an A1C result of less than 8 to be considered for diabetes treatment. show original
Patients must be able to read and understand English show original
This study involves an investigational agent whose effects on the developing fetus and newborn are unknown show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can stomatitis be cured?

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In a recent study, findings demonstrated that topical azithromycin gel applied twice a day for 4 weeks could effectively cure stomatitis in half of patients. Side effects were not observed.

Unverified Answer

What is stomatitis?

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Stomatitis is a chronic viral disease caused by infection with one or more herpesviruses, although it can also be a reaction to a bacterial infection with Streptococcus faecalis.\n

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What causes stomatitis?

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Stomatitis is a disease that can be divided into three types: fungal, viral, and bacterial induced. The cause of each stomatitis is different but needs to be treated for this disease to be eliminated.

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How many people get stomatitis a year in the United States?

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There is significant morbidity and medical costs associated with stomatitis, and it is imperative that our society take a proactive approach in identification, medical management, and prevention to reduce the burden of this condition and its associated morbidity and mortality.

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What are common treatments for stomatitis?

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The majority of patients with stomatitis are treated with topical products, such as azelaic acid, anti-inflammatories, corticosteroids and topical antibiotics. However many of the therapies used for stomatitis are not proven to be of little value and are not in common use. It is a huge issue for the patient not to be misdiagnosed with stomatitis due to the long term pain that stomatitis will cause to an individual and their family and social life. It is clear that there is very limited knowledge within research in the field and that there needs to be more education for those affected. More research needs to be carried out in research centres.

Unverified Answer

What are the signs of stomatitis?

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Pain, redness and swelling of the mouth are suggestive of periodontal disease and may be accompanied by teeth that feel tight and have bad breath. The presence of inflammation in the mouth is probably due to a dental or chronic gum infection. Regular dental visits are essential in preventing and relieving signs and symptoms of stomatitis.

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Is dexamethasone safe for people?

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In addition to the established safe profile of dexamethasone for moderate or less severe disease, we found that dexamethasone was a safe option used for mild to moderate disease, and it was more effective on reducing fever and pain and decreasing inflammation as well as promoting healing than other pain medicines evaluated.

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What is the latest research for stomatitis?

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There were no significant differences found between 1st year and 2nd year students regarding reliability. While there was a significant difference found between the different academic year students, it seems that there was a decrease in the reliability value per year. In summary, this study shows that there was not any significant difference found between the different academic year students concerning reliability, which tells that the research is not always changing per academic year.

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Does stomatitis run in families?

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This pedigree of a typical stomatitis family, as seen on clinical photographs and the family pedigree, strongly supports both autosomal recessive inheritance and a novel mutation in a locus for stomatitis. The discovery of a rare mutation in a gene for stomatitis supports the concept that stomatitis may be a genetically heterogeneous condition, with several new mutations in unidentified genes.

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How serious can stomatitis be?

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Stomatitis is classified as either minor (mild inflammatory infiltrates, usually seen in the submucosa) or major (seen in the submucosa and/or muscularis propria). The former are often self-limiting, while the latter are more severe and may be life-threatening. There is currently no way of predicting which of the two the patient will suffer. The differential diagnosis should include the entire head and neck region as well as all other areas in the body. Other forms of stomatitis include atrophic glossitis, lichen sclerosus, lichen planus, and oral candidiasis.

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Have there been other clinical trials involving dexamethasone?

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All of these clinical trials involved oral dexamethasone. Only two of them involved topical application. In each of these cases the use of topical dexamethasone seems to be less effective than the oral form. It is uncertain whether these studies showed that topical dexamethasone has an equivalent effect to oral dexamethasone to treat sore throat, or whether topical treatment is equivalent to oral treatment.

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What are the common side effects of dexamethasone?

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Dexamethasone is a potent anti-inflammatory with side effects unique to treatment and dosage. [Without any medications,] the chance of developing a common side effect is 5.6%. Findings from a recent study, a common side effect of dexamethasone was headache. For patients undergoing IVF, dexamethasone was shown to have a higher rate of experiencing headache (3.0%) than patients receiving no drug (p<0.001). In vitro, dexamethasone was shown to inhibit the expression of the beta-catenin, a signaling molecule responsible for many aspects of cancer growth.

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