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

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ClinicalTrials.gov Identifier: NCT01569724
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Cutaneous T Cell Lymphoma Other: oral glucose tolerance test (OGTT) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study
Study Start Date : January 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : April 2017

Arm Intervention/treatment
Experimental: bexarotene Other: 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
Other Name: Non applicable.

Primary Outcome Measures :
  1. glucose intolerance or diabetes [ Time Frame: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene. ]
    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.

Secondary Outcome Measures :
  1. hypothyroidism [ Time Frame: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene. ]
    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.

  2. response to bexarotene [ Time Frame: At 0, 2, 4, 6, 8 weeks after the administration of 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%.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569724

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Service de dermatologie - Hôpital de Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
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Principal Investigator: Henri ADAMSKI, MD Rennes University Hospital
Study Chair: Emmanuel OGER, MD, PhD Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01569724    
Other Study ID Numbers: 2010-A23465-21
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by Rennes University Hospital:
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Metabolic Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lipid Metabolism Disorders