Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma

Study Overview
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Brief Summary
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Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not well known. The purpose of this study is to research a carbohydrate metabolism disorder associated in bexarotene-induced hypertriglyceridemia.

Detailed Description
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Primary cutaneous lymphomas are the second group of extra nodal lymphomas after gastrointestinal lymphomas. Bexarotene is licensed for the treatment of epidermotropic cutaneous T cell lymphoma .The most common side effect of bexarotene is hypertriglyceridemia (82%) associated with hypercholesterolemia (30 to 40%). Central hypothyroidism is also present in 40-80% of cases. These adverse effects are dose-dependent. The management of hyperlipidemia induced by bexarotene is difficult. The mechanism of lipid disorder induced by bexarotene is not well known. Associated carbohydrate metabolism disorder could be present and play a role in the bexarotene-induced hyperlipidemia. The main objective is to estimate the frequency of a carbohydrate disorder in patients with hypertriglyceridemia (TG> 1.5 g / L) induced by bexarotene treatment of cutaneous T cell lymphoma, previously free of diabetes, thyroid dysfunction and dyslipidemia.

Official Title
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Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study

Conditions
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Hypertriglyceridemia, Cutaneous T Cell Lymphoma

Intervention / Treatment
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* Other: oral glucose tolerance test (OGTT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged over 18 years Diagnosis of epidermotropic CTCL confirmed by histological examination for which consideration will be given treatment with bexarotene due to the advanced stage of lymphoma (stage IIB-IV) or earlier stage if resistance to previous treatment . TSH, FT3 and FT4 within normal limits AST and ALT ≤ 2 * upper limit of normal Creatinine clearance ≥ 30 mL / min Agreement after written information and informed to participate in the study Patient accepting the constraints of the study Membership of a social security system. Exclusion Criteria: Pregnant or lactating woman Women of childbearing potential without effective contraception Insufficient thyroid or hyperthyroidism Diabetes known or detected Hyperlipidemia known or detected Hepatic insufficiency Difficulties to understand Persons covered by a plan of legal protection (protection of justice, guardianship, curator) or unable to issue a consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bexarotene<br> | Other: oral glucose tolerance test (OGTT)<br>* patients presenting an hypertriglyceridemia will have a oral glucose tolerance test (OGTT) in order to diagnose a carbohydrate metabolism disorder<br>* Other names: Non applicable.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose intolerance or diabetes | The presence of a carbohydrate disorder is defined by glucose intolerance or diabetes. The diagnosis of glucose intolerance is made for a fasting glucose less than 1.26 g / l glucose and 2 hours (T120mn) after taking 75 g of glucose during an oral glucose tolerance test (OGTT) between 1.4 and 2 g / l and / or a value greater than or equal to 2 g / l between T30 and T90 min. Diabetes is established for a fasting glucose greater than or equal to 1.26 g / l and / or blood glucose greater than or equal to 2 g / l to 2 hours. | At 0, 2, 4, 6, 8 weeks after the administration of bexarotene. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypothyroidism | hypothyroidism detection: TSH, free T3 and free T4 measured weekly during the first month and then every 15 days in the second month. Laboratory abnormalities will be evaluated according to the standards of the laboratory of each center. | At 0, 2, 4, 6, 8 weeks after the administration of bexarotene. | 
| response to bexarotene | Response to bexarotene: it is considered partial if the patient has a decrease in injuries between 50% and 90% to total as if it has a lower damage of more than 90%. | At 0, 2, 4, 6, 8 weeks after the administration of bexarotene. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertriglyceridemia, bexarotene