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

NCT ID: NCT01569724

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2017-04-30

Brief Summary

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

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.

Conditions

Hypertriglyceridemia; Cutaneous T Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bexarotene

Group Type: EXPERIMENTAL

oral glucose tolerance test (OGTT)

Intervention Type: OTHER

patients presenting an hypertriglyceridemia will have a oral glucose tolerance test (OGTT) in order to diagnose a carbohydrate metabolism disorder

Interventions

oral glucose tolerance test (OGTT)

patients presenting an hypertriglyceridemia will have a oral glucose tolerance test (OGTT) in order to diagnose a carbohydrate metabolism disorder

Intervention Type: OTHER

Other Intervention Names

Non applicable.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henri ADAMSKI, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Emmanuel OGER, MD, PhD

Role: STUDY_CHAIR

Rennes University Hospital

Locations

Service de dermatologie - Hôpital de Pontchaillou

Rennes, , France

Countries

France

Other Identifiers

2010-A23465-21

Identifier Type: -

Identifier Source: org_study_id