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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Withdrawn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
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Haematological Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 20, 2018
    Last Updated
    March 28, 2023
    Sponsor
    Rennes University Hospital
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    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

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