CLINICAL TRIAL

Treatment for Mouth Neoplasms

Waitlist Available · 18+ · All Sexes · Columbus, OH

This study is evaluating whether a strawberry gummy can help improve oral health in people who are undernourished.

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About the trial for Mouth Neoplasms

Eligible Conditions
Oral Health · Gum Disease · Mouth Neoplasms · Oral Cancers

Treatment Groups

This trial involves 2 different treatments. Treatment 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 1 and are in the first stage of evaluation with people.

Control Group 1
Strawberry gummy
OTHER
Control Group 2
Placebo control gummy
OTHER

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The participant must agree to consume a standardized vitamin and mineral supplement and to avoid other nutritional, dietary, or alternative medications/supplements for the duration of the study. show original
is classified as overweight, and a BMI of more than 35 kg/m2 is classified as obesity show original
Meet one of the following smoking criteria
A non-smoker is someone who doesn't smoke. show original
The individual has no history of any metabolic disorders that would require them to follow a special diet. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 0, 7, 21, 28
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 0, 7, 21, 28.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Mouth Neoplasms. Measurement will happen over the course of Day 0, 7, 21, and 28.

Quantify the enteral absorption and excretion patterns of strawberry polyphenols in smoking and non-smoking healthy adult men and women consuming the strawberry and placebo gummies.
DAY 0, 7, 21, AND 28
This data will be used to define relationships between dietary intake, polyphenol metabolism and the biological outcomes examined in tertiary outcome. Pharmacokinetics of strawberry polyphenols in saliva following consumption of a single dose delivering two 6 gram fruit gummies will be compared in smoking and non-smoking men and women consuming the strawberry or placebo gummies. Prevalent strawberry polyphenols and their metabolites in saliva, serum, and urine will be assessed and compared with strawberry gummy type consumed.
Measure salivary inflammatory markers and gene expression profiles in oral mucosa that promote oral health following short-term exposure to strawberry fruit polyphenol.
DAY 0, 7, 21, 28
Salivary inflammatory markers (cortisol, Ig A, and 8-hydroxydeoxyguanosine) following consumption of strawberry and placebo gummies will be compared in smoking and non-smoking men and women. Expression profiling will be examined on RNA obtained from longitudinal buccal brushings and plasma utilizing qRT-PCR and SuperArray's RT2 Profiler™ PCR Array (Inflammation Panel) containing 84 genes unique to the inflammation pathway and compared with strawberry gummy type consumed.
Achieve excellent compliance and minimal toxicity with consumption of the strawberry gummies.
ONE WEEK AFTER INTERVENTION
Daily records of consumption will be maintained. Standardized qualitative and quantitative toxicity criteria (NIH Common Terminology Criteria for Adverse Events, v. 3.0) will be employed to describe the safety as well as incidence toxicity

Who is running the study

Principal Investigator
Y. V.
Prof. Yael Vodovotz, Associate Professor
Ohio State University

Patient Q & A Section

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

What is the latest research for mouth neoplasms?

The management of oral cavity malignancies is extremely complex and involves interaction between many disciplines to deliver effective and sustainable treatment. It is critical that our patients are appropriately counseled and informed regarding the latest research of their condition. Our aim is to give you the latest evidence to use in your practice.

Anonymous Patient Answer

What are the signs of mouth neoplasms?

Signs of mouth neoplasms may include a black (melanotic) appearance on the tongue, swollen and tender lymph nodes, or an enlarged neck mass. Malignant lesions may have a foul-smelling, bad breath, or painful and dry lips.\n

Anonymous Patient Answer

What causes mouth neoplasms?

Oral neoplasms are a very common condition with almost one third of all new patients in tertiary general/dermatology/plastic surgery centres presenting with them. Most oral tumors are benign and, by and large, can be managed effectively by careful use of modern local excision techniques. However, recurrences are likely and repeated treatment required. However, in the early stages, the clinical picture is frequently that of a malignant lesion. Further work is required to define the best management protocol for benign and malignant lesions. In addition, a greater understanding of the genetic and environmental factors that lead to malignant transformation of oral mucosa is required.

Anonymous Patient Answer

What are common treatments for mouth neoplasms?

Many treatment options are employed in the management of a vast range of oral cavity cancers. These options may range from simple supportive care to radical surgery and complex adjuvant approaches. Despite the potential for complex multimodal treatment, most of the procedures used in managing these diseases are simple and straightforward.

Anonymous Patient Answer

What is mouth neoplasms?

The current literature reviewed identifies no studies that have addressed the oral cavity as a site for tumors. Despite its location and proximity to the mouth, oral cancer does not appear to be a common neoplasm on the oral.

Anonymous Patient Answer

How many people get mouth neoplasms a year in the United States?

1,600 new cases of oral cancer were diagnosed in the United States in 2006. The average age was 58.2 years. The male to female ratio was approximately 1.5:1. Approximately 85% of the tumors were squamous cell carcinomas and approximately 11% of the tumors were adenocarcinomas. A majority (62%) of the tumors were in the gingiva.

Anonymous Patient Answer

Can mouth neoplasms be cured?

Data from a recent study suggest that treatment with oral agents can modify some aspects of tumor biology and consequently, can result in significant tumor shrinkage. Further studies regarding the biologic interactions between tumor and oral environment and their correlation with tumor-specific treatments should be conducted.

Anonymous Patient Answer

Have there been any new discoveries for treating mouth neoplasms?

There are many different types of mouth neoplasms, they may vary in their type and location, and require surgery, radiation therapy, and chemotherapy. Patients that may benefit from these treatments may not have their treatment or disease progression monitored. It is important for patients to start their treatment with the right physician.

Anonymous Patient Answer

What are the common side effects of treatment?

Cisplatin is an exciting regimen for patients with oral squamous carcinoma because of its excellent degree of antitumor activity and reasonably few toxicities, as well as its low frequency of use and low cost of treatment relative to other chemoradiotherapy regimens.

Anonymous Patient Answer

What is treatment?

Many subjects were treated with topical drugs while not taking pills or injectons. The only medications (with the possible exception of some antifungals and antitoxins) taken by more than half of the patients were [pain killers (pain-relieving drugs)] and topical medications. There was no single class of medicines (anti-inflammatory, anti-bacteria, anti-fungal, etc.) that was more frequently used than others.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

At the present time, only two clinical trials have been published and no large trial has been completed. Nevertheless, these trials have shown that there is a positive overall survival and DFS when comparing treatment with a placebo, and that when the cancer has received a new type of treatment, an improvement in survival is also obtained. However, we only need to administer treatment to patients whose cancer has not received new treatment; we can thus infer that other treatments would be required in these situations.

Anonymous Patient Answer

What are the chances of developing mouth neoplasms?

In order to make definitive decisions on the need of a full-scale dental examination for high-risk people, epidemiological, behavioral factors, and clinical history should be considered together, as there is almost a 100% chance of acquiring some form of oral neoplasms.

Anonymous Patient Answer
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