Treatment for Syndrome

Phase-Based Estimates
2
Effectiveness
3
Safety
UF Health Cancer Center, Gainesville, FL
Syndrome+3 More
Eligibility
18+
All Sexes
Eligible conditions
Syndrome

Study Summary

This study is evaluating whether a diet inclusive of fresh fruits and vegetables is as safe as a neutropenic diet for individuals with prolonged neutropenia.

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Eligible Conditions

  • Syndrome
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Treatment Effectiveness

Effectiveness Estimate

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

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 10 secondary outcomes in patients with Syndrome. Measurement will happen over the course of 1 year.

1 year
Admission frequency
Compliance
Incidence of graft vs.host disease (GVHD)
Incidence of infections in each diet group
Incidence of major infections
Incidence of mucositis
Overall survival (OS)
Patient-Generated Subjective Global Assessment (PG-SGA)
Progression free survival (PFS)
Quality of life (QoL)
Symptom incidence

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Neutropenic Diet (Diet B)

This trial requires 470 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Neutropenic Diet (Diet B)
Other
Diet B is the hospital neutropenic diet.
Liberalized Hospital Diet (Diet A)
Other
Diet A would include fresh fruits and/or fresh vegetables in a liberalized hospital diet, and subjects will be encouraged to eat at least one daily serving of fresh fruits and/or vegetables.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

UF Health Cancer Center - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with leukemia who are receiving chemotherapy that is expected to cause them to have a neutropenia of seven days or more are allowed to stay in the hospital. show original
Any person aged 18 or older is considered an adult in the eyes of the law. show original
The expected duration of neutropenia is seven days or more. 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 syndrome be cured?

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Patients presenting with acute TBI and MTS may not be capable of an effective response to steroids. At this time, there are no randomised trials showing that it is possible to positively impact syndrome by using a steroid, but this research is still in the pre-clinical stages. Our patients received appropriate steroid treatments at the onset of symptoms, and their syndrome ameliorated and improved within 24 hrs of administering steroids.

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Have there been other clinical trials involving treatment?

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There is a significant need for a multicenter, high-quality clinical trial. All patients with chronic lymphocytic leukemia should be eligible for such a clinical trial.

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What are the signs of syndrome?

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Symptoms of the syndrome are not specific for any one underlying cause of arthritis and include fatigue, nausea and vomiting, weight loss, change in skin color, and gastrointestinal and musculoskeletal complaints. While fever occurs frequently with all forms of arthritis, it is not a characteristic sign of syndrome.

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What is syndrome?

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Syndromes describe a syndrome by combining symptom patterns. In its literal meaning, the word syndrome itself has several meanings depending in which context it is used. In clinical contexts that rely on clinical diagnosis of the most common symptom patterns, the literal meaning of syndrome is the most relevant.

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What are common treatments for syndrome?

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Treatment of syndromes is often based on patient's medical consultation and experience rather than following a uniform approach. Some common treatments or syndromes include headaches, obesity, sleep apnea, and asthma.

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

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About 1.8 million people n this United States will develop syndrome in 2022, and 2 million of them will die as a direct result of their current disease.

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What causes syndrome?

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There are several factors that can cause syndromes: physical health problems, social relationships, and psychological issues. Syndromes may also occur because of an unusual buildup of environmental information that accumulates in the CNS.

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Who should consider clinical trials for syndrome?

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There is considerable geographical variability in the identification and enrollment of individuals with a syndromal symptom for whom clinical trials might provide a useful diagnosis or improve symptom management. Identifying patients who might gain from clinical trials would improve overall care.

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What does treatment usually treat?

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Clinicians should assess their patients' knowledge of their symptoms and the need for treatment by asking a number of questions, most importantly concerning if the symptom(s) are a result of underlying health problems not alleviated by standard treatments. The need for treatment should be assessed and, if applicable, the treatment(s) suggested.

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What are the common side effects of treatment?

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The most common side-effects of treatment are related to the side-effects of the test drugs used in the treatment. These side-effects can cause a lot of psychological and socio-economic difficulties. The most common side effects of treatment are nausea (33.3%), vomiting (31.5%) and sweating (11.2%).

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Does treatment improve quality of life for those with syndrome?

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A significant number of patients who survive colon cancer may experience postoperative morbidities. More stringent investigation is needed before an active treatment program can be proposed.

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Have there been any new discoveries for treating syndrome?

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The syndrome has only been investigated in very limited trials and the conclusions are not very reliable. There is also a need for trials on patients who have the condition in all age ranges and for trials of treatment with different medications. There is also need for the patient's age to be ascertained and for them to be followed up yearly to make sure they are being well treated.

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