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NCT Number: NCT01569724

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

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.

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Key information

Conditions

Hypertriglyceridemia Cutaneous T Cell Lymphoma Dyslipidemias Hemic and Lymphatic Diseases Hyperlipidemias Immune System Diseases Immunoproliferative Disorders Lipid Metabolism Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service de dermatologie - Hôpital de Pontchaillou

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral glucose tolerance test (OGTT)

Other

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

Other names: Non applicable.

Primary outcomes

  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 outcomes

  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%.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: TgBEX

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Apr 3, 2012
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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