Quality-of-Life Assessment for Paraganglioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic, Rochester, MN
Paraganglioma+5 More
Quality-of-Life Assessment - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether lenvatinib is effective in treating patients with pheochromocytoma or paraganglioma that has spread to other places in the body or cannot be removed by surgery.

See full description

Eligible Conditions

  • Paraganglioma
  • Metastatic Adrenal Gland Pheochromocytoma
  • Malignant Adrenal Gland Pheochromocytoma
  • Paraganglion neoplasm malignant

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Paraganglioma

Study Objectives

This trial is evaluating whether Quality-of-Life Assessment will improve 1 primary outcome, 5 secondary outcomes, and 3 other outcomes in patients with Paraganglioma. Measurement will happen over the course of Monthly, up to 17 months..

Month 17
Progression-free Survival
Month 17
Duration of Tumor Response
Overall Survival Time
Month 17
Confirmed Tumor Response Rate
Patients Evaluable for Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Up to 5 years
Changes in Urinary Catecholamine and Metanephrine Levels
Germline Mutational Status in Peripheral Blood Mononuclear Cells
Quality of Life Assessed by EQ-5D and FACT-G
Somatic Mutational Status in Peripheral Blood Mononuclear Cells

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Paraganglioma

Trial Design

1 Treatment Group

Treatment (lenvatinib)
1 of 1
Experimental Treatment

This trial requires 3 total participants across 1 different treatment group

This trial involves a single treatment. Quality-of-Life Assessment 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 2 and have already been tested with other people.

Treatment (lenvatinib)Patients receive lenvatinib PO once daily on days 1-28. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Mayo Clinic - Rochester, MN

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 enzyme aspartate transaminase (AST) should not be more than 2.5 times the upper limit of normal (ULN) in the serum. show original
The total bilirubin should be less than 1.5 times the upper limit of normal, or less than 3.0 times the upper limit of normal if the direct bilirubin is less than 1.5 times the upper limit of normal in patients with Gilbert's Syndrome. show original
The person has a white blood cell count of 3,000 or more per cubic millimeter. show original
The platelet count is more than 100,000 per cubic millimeter. show original
A pheochromocytoma or paraganglioma is found to be cancerous and cannot be surgically removed show original
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
The life expectancy of a baby who is born after 24 weeks of pregnancy is greater than 24 weeks. show original
A blood test result that shows an absolute neutrophil count of at least 1500 cells per milliliter of blood. show original
For Hemoglobin levels, the cutoff is >= 9.0 g/dL (5.6 mmol/L); however, note that transfusions are not allowed =< 7 days prior to registration. show original

Patient Q&A Section

Have there been other clinical trials involving quality-of-life assessment?

"There is considerable tension inherent in a study of psychological outcomes. However, to minimize this tension, and to minimize the potential impact on the study's internal validity, quality-of-life assessment is highly recommended during clinical trials as one of the best outcome measures." - Anonymous Online Contributor

Unverified Answer

Does pheochromocytoma run in families?

"This case highlights the importance of genetic testing for the diagnosis of metastasizing extra-adrenal pheochromocytoma in family members of a patient with a nonfunctioning adrenal pheochromocytoma." - Anonymous Online Contributor

Unverified Answer

What causes pheochromocytoma?

"Given the large number of inherited conditions known to predispose to pheochromocytoma, geneticists suspect that pheochromocytoma will be found to have an additional hereditary cause in the future. The possibility that the "first tumor" of a multiple endocrine neoplasia (MEN) syndrome is actually a pheochromocytoma warrants further investigation." - Anonymous Online Contributor

Unverified Answer

What are the signs of pheochromocytoma?

"Symptoms of hypertension, sweating, palpitations, and increased appetite or weight loss are possible, and can occur in pheochromocytoma, with paroxysmal, episodic, or chronic events. The only conclusive symptom of pheochromocytoma is high blood pressure." - Anonymous Online Contributor

Unverified Answer

What is pheochromocytoma?

"A pheochromocytoma is a rare tumor that arises in the adrenal medulla, which is normally located within the adrenal gland. It was first identified by the English physician Henry Maudsley in 1873; in his memoirs, Maudsley said that he first noticed an unusual abdominal pain and syncope when he was working as an assistant to the famed surgeon Charles Bright. Maudsley described in detail the features of this rare tumor. However, the cause of this tumor was identified in 1933, when it was reported to have arisen from the chromaffin cells in the adrenal glands of a 40-year-old man." - Anonymous Online Contributor

Unverified Answer

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

"About 70,000 pheochromocytomas, including both sporadic and familial forms, are diagnosed annually in the United States. This disorder is, therefore, one of the most frequent endocrine tumors in the country. We consider pheochromocytoma a rare disease, but must evaluate all patients, including those whose tumor is not easily noticed, because it is still the most common endocrine tumor." - Anonymous Online Contributor

Unverified Answer

Can pheochromocytoma be cured?

"This paper discusses the indications for adrenalectomy, the potential effects of resection on cancer control and adrenal gland function, and the role of adrenalectomy in the management of patients with pheochromocytoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pheochromocytoma?

"Pheochromocytoma is treated with dopamine-releving agents such as aminorex, pyridoxal-5'-phosphate, levodopa with a peripheral dopamine receptor antagonist such as alpha-methyl-D-tyrphenylalanine, and alpha-methyl-D-tyrosine in addition to alpha-dihydrotetrabenazine and metaiodobenzylguanidine as part of multidisciplinary treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets pheochromocytoma?

"The average age of diagnosis (47 years) is well below what would be expected, and has had repercussions on both the patient's and their family's well-being throughout the duration. Therefore, prompt diagnosis and treatment are necessary to ensure that patients have the best possible outcomes. At the same time, research should be made to determine whether these patients would benefit from a periodic surveillance regimen of abdominal imaging." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of pheochromocytoma?

"Because this tumor can produce significant, disabling symptoms, it is essential that the clinician not delay diagnosis. [If your symptoms did not improved on dietary exclusion, then your pheochromocytoma must be tested. If it is found that these symptoms were caused by a high blood pressure unrelated to diabetes, treatment will require an early diagnosis, a sympathomimetic drug, and follow-up with another blood pressure test. If the patient continues to have these symptoms for more than one month, the clinician should evaluate other possible causes to rule out alternative diagnoses; if other possible diseases can not be ruled out, then surgical removal may be appropriate. For patients whose symptoms have persisted despite ongoing treatment, surgical removal could be considered." - Anonymous Online Contributor

Unverified Answer

How serious can pheochromocytoma be?

"In this population study of patients referred for a head and/or neck CT, the prevalence of clinically significant and/or life-threatening intracranial tumors was relatively<3% in symptomatic patients with a mean age of 60 years. These imaging findings could potentially prompt a surgical intervention." - Anonymous Online Contributor

Unverified Answer

What does quality-of-life assessment usually treat?

"Patients with pheochromocytoma or Cushing's syndrome report similar changes in HRQOL from treatment that improves symptoms, and treatment may be particularly effective for those with diabetes. However, HRQOL for patients with pheochromocytoma decreases after completion of treatment, and improvement of symptoms in patients with Cushing's syndrome, unlike that in patients with diabetes, may be attributable to improved comorbidities rather than treatment. HRQOL may play an important role in decision making in the evaluation and treatment of patients with pheochromocytoma and Cushing's syndrome." - Anonymous Online Contributor

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