Hématologie Adulte Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology (HemaSur)
Primary Purpose
Haematological Malignancy
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydrocortisone supplementation
Sponsored by
About this trial
This is an interventional diagnostic trial for Haematological Malignancy
Eligibility Criteria
Inclusion Criteria:
- Age> 18 years
- Patient naive to any chemotherapy treatment, re-ceiving a 1st chemotherapy line of RCHOP, RCOP, VTD, VD or MPT type from the Adult Hematology Department
- PS according to WHO = 0,1 and 2
Exclusion Criteria:
- Adrenal pathology, hypothalamus or pre-existing pituitary gland (including metastatic lesions)
- Long-term treatment with corticosteroids or in the previous 6 months
- Refusal or absence of informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hydrocortisone supplementation
Arm Description
Outcomes
Primary Outcome Measures
Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session
Cortisol at T0 and T30mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session
Secondary Outcome Measures
cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure
cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure
potential drug interactions (including CYP450 inducer)
potential drug interactions (including CYP450 inducer)
Evaluation of the effect on quality of life of Hydrocortisone supplementation in patients with biological IS in the wake of EORTC QLQ-C30 type self-administered chemotherapy at D0 and D30
Evaluation of the effect on quality of life of Hydrocortisone supplementation in patients with biological IS in the wake of EORTC QLQ-C30 type self-administered chemotherapy at D0 and D30
Full Information
NCT ID
NCT03688789
First Posted
September 20, 2018
Last Updated
March 28, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03688789
Brief Title
Hématologie Adulte Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology
Acronym
HemaSur
Official Title
Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator leaving the hospital
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A recent meta-analysis involving 3753 patients treated with corticosteroids notes that the population with the highest prevalence of biological IS (68%) is onco-hematology. However, it is also the least studied population with no recent and significant prevalence study. A recent multicenter study including patients followed up oncology who received dexamethasone for antiemetic purposes at cumulative doses well below the doses used in Hematology, objective a prevalence of biological IS estimated at 16% at 3 months from the start of chemotherapy. The introduction of a substitution had led to an objective improvement in the quality of life estimated by EORTC QLQ-C30.
Detailed Description
A recent meta-analysis involving 3753 patients treated with corticosteroids notes that the population with the highest prevalence of biological IS (68%) is onco-hematology. However, it is also the least studied population with no recent and significant prevalence study. A recent multicenter study including patients followed up oncology who received dexamethasone for antiemetic purposes at cumulative doses well below the doses used in Hematology, objective a prevalence of biological IS estimated at 16% at 3 months from the start of chemotherapy. The introduction of a substitution had led to an objective improvement in the quality of life estimated by EORTC QLQ-C30.
Expected results are prevalence rate of biological adrenal insufficiency between 15 and 20% with improvement of the quality of life in the 2 months post-chemotherapy by Hydrocortisone supplementation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haematological Malignancy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrocortisone supplementation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Hydrocortisone supplementation
Intervention Description
Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session
Hydrocortisone supplementation in patients with biological adrenal insufficiency
scale of quality of life estimated by EORTC QLQ-C30
Primary Outcome Measure Information:
Title
Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session
Description
Cortisol at T0 and T30mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session
Time Frame
30 min
Secondary Outcome Measure Information:
Title
cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure
Description
cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure
Time Frame
6 months
Title
potential drug interactions (including CYP450 inducer)
Description
potential drug interactions (including CYP450 inducer)
Time Frame
6 months
Title
Evaluation of the effect on quality of life of Hydrocortisone supplementation in patients with biological IS in the wake of EORTC QLQ-C30 type self-administered chemotherapy at D0 and D30
Description
Evaluation of the effect on quality of life of Hydrocortisone supplementation in patients with biological IS in the wake of EORTC QLQ-C30 type self-administered chemotherapy at D0 and D30
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age> 18 years
Patient naive to any chemotherapy treatment, re-ceiving a 1st chemotherapy line of RCHOP, RCOP, VTD, VD or MPT type from the Adult Hematology Department
PS according to WHO = 0,1 and 2
Exclusion Criteria:
Adrenal pathology, hypothalamus or pre-existing pituitary gland (including metastatic lesions)
Long-term treatment with corticosteroids or in the previous 6 months
Refusal or absence of informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brieuc Cherel, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hématologie Adulte Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology
We'll reach out to this number within 24 hrs