Clinical trial NCT01569724: Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma
Official title: Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertriglyceridemia
Cutaneous T Cell Lymphoma
Keywords: hypertriglyceridemia
bexarotene
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: glucose intolerance or diabetes
timeFrame: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
Secondary outcomes:
measure: hypothyroidism
timeFrame: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
measure: response to bexarotene
timeFrame: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service de dermatologie - Hôpital de Pontchaillou
Study officials:
affiliation: Rennes University Hospital
name: Henri ADAMSKI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Emmanuel OGER, MD, PhD
role: STUDY_CHAIR
References: