Patients treated with cabozantinib s-malate or lenvatinib mesylate are observed for body weight, skeletal muscle and adipose tissue changes. Patients complete 3 to 4 questionnaires every 2 weeks for 6 months and then monthly up to 12 months. Patients also undergo physical assessments and body composition measurements by DXA and CT scans at baseline, months 3, 6, and 12.

Differentiated Thyroid Gland Carcinoma

Malignant Adrenal Gland Pheochromocytoma

Malignant Paraganglioma

Thyroid Gland Medullary Carcinoma

Computed Tomography

Dual X-ray Absorptiometry

Physical Examination

Quality-of-Life Assessment

Questionnaire Administration

Cabozantinib

Lenvatinib

University of Texas MD Anderson Cancer Center Website

M D Anderson Cancer Center

Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer

Effects of Tyrosine Kinase Inhibitors on Body Composition in Endocrine Tumors -- A Pilot Study

2-sided paired t-test will be used to measure weight change after successful intervention of diarrhea and anorexia. Linear mixed-effects model will be used to explore the longitudinal weight changes. Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, gastrointestinal adverse events, body composition changes and blood markers. 95% confidence intervals (CI) will be reported for the accuracy of DXA compared to computed tomography CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression.

Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, body composition changes and blood markers. 95% CI will be reported for the accuracy of DXA compared to CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression.

Summary descriptive statistics, including proportions, medians, means, 95% confidence intervals, and other simple statistics will be provided for demographics, tumor response rates and blood markers. 95% CI will be reported for the accuracy of DXA compared to CT. The correlation between change of weight/body composition and tumor response will be investigated by logistic regression.

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Prothelial: Arm 1 Patients with oroesophageal mucositis (with pain, erythema, ulceration and difficult pain swallowing as prominent symptom/signs) [n=30] Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and swallow. (Phase I)

Prothelial: Arm 2 Patients with gastric/small intestinal mucositis (delayed nausea, vomiting as prominent symptom/sign) [n=30] Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and swallow. (Phase I)

ProThelial: Arm 3 Patients with lower GI mucositis develop chemoradiation diarrhea as their \ prominent symptom/sign[n=30]. Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and swallow. (Phase I)

ProThelial: Arm 4 Patients anticipated to develop oroesophageal mucositis (with pain, erythema, ulceration and difficult pain swallowing as prominent symptom/signs) [n=30] Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and spit. (Phase IV)

ProThelial: Arm 5 Patients anticipated to develop gastric/small intestinal mucositis (delayed nausea vomiting as prominent symptom/sign) [n=30]. Intervention: ProThelial 1.5 gram Taken tid x 2 days then bid swish and swallow. (Phase I)

ProThelial: Arm 6 Patients anticipated to develop chemoradiation diarrhea as their prominent symptom/sign [n=30]. Intervention: ProThelial 1.5 gram taken tid x 2 days then bid swish and swallow. (Phase I)

Oral Mucositis

Nausea

Vomiting

Diarrhea

August 2013, the FDA cleared the use of ProThelial, a polymerized high potency sucralfate paste, as a device for the management of oral mucositis.Standard potency non-polymerized sucralfate is not recommended by MASCC/ISOO for the treatment or prevention of mucositis, oral or alimentary. However high potency polymerized sucralfate has been associated with rapid amelioration and prevention of both oral and alimentary mucositis in a patient with advanced head neck cancer treated simultaneously with high dose chemo-radiation. High potency sucralfate is standard sucralfate polymerized into 'sucralfate sheets' that adhere and orderly layer upon the mucosa achieving and maintaining elevated concentrations of sucralfate long after the initial dose administration. Three hours following administration, high potency sucralfate maintains a 7 fold greater surface concentration of sucralfate on normal lining and a 23 fold greater concentration on inflamed, ulcerated mucosa.

ProThelial

Translational Medicine Research Center

ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial

Treatment and Prevention of Oral and Alimentary Mucositis Using Polymerized Cross-Linked High Potency Sucralfate as a Single Agent Therapy

Measures are to report the change from baseline in the OMAS used to assess patient in the prevention of oral mucositis by ProThelial (Phase IV)

Measures are to report the change from baseline in the OMAS used to assess patient in the treatment of oral mucositis by ProThelial (Phase IV)

PVAS is to be used to assess patient-reported pain of chemoradiation mucositis while under treatment with ProThelial (Phase IV)

DSVAS will be used to assess difficulty in swallowing in patients with chemoradiation mucositis under treatment with ProThelial (Phase I)

NCI Toxicity Grading of Alimentary Mucositis will be used to assess the degree of nausea, vomiting and diarrhea caused by chemoradiation (Phase I).

malate/diarrhea

Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer

ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial

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