Hématologie Adulte Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Haematological Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hydrocortisone supplementation

Group Type EXPERIMENTAL

Hydrocortisone supplementation

Intervention Type OTHER

* 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

Interventions

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Hydrocortisone supplementation

* 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No