Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma (TgBEX)
Primary Purpose
Hypertriglyceridemia, Cutaneous T Cell Lymphoma
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
oral glucose tolerance test (OGTT)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring hypertriglyceridemia, bexarotene
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
Sites / Locations
- Service de dermatologie - Hôpital de Pontchaillou
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bexarotene
Arm Description
Outcomes
Primary Outcome Measures
glucose intolerance or diabetes
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
hypothyroidism
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.
response to 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%.
Full Information
NCT ID
NCT01569724
First Posted
February 24, 2012
Last Updated
July 19, 2017
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01569724
Brief Title
Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma
Acronym
TgBEX
Official Title
Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia, Cutaneous T Cell Lymphoma
Keywords
hypertriglyceridemia, bexarotene
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bexarotene
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
oral glucose tolerance test (OGTT)
Other Intervention Name(s)
Non applicable.
Intervention Description
patients presenting an hypertriglyceridemia will have a oral glucose tolerance test (OGTT) in order to diagnose a carbohydrate metabolism disorder
Primary Outcome Measure Information:
Title
glucose intolerance or diabetes
Description
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.
Time Frame
At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
Secondary Outcome Measure Information:
Title
hypothyroidism
Description
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.
Time Frame
At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
Title
response to bexarotene
Description
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%.
Time Frame
At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri ADAMSKI, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel OGER, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Service de dermatologie - Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Learn more about this trial
Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma
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