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

July 19, 2017 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Service de dermatologie - Hôpital de Pontchaillou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Non applicable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
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%.
At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Henri ADAMSKI, MD, Rennes University Hospital
  • Study Chair: Emmanuel OGER, MD, PhD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (ESTIMATE)

April 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A23465-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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