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

Not Applicable

Withdrawn

• Conditions: Haematological Malignancy
• Interventions: Other: Hydrocortisone supplementation

• Registration Number: NCT03688789
• Lead Sponsor: Rennes University Hospital

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

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Study Start: 2019-01-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrocortisone supplementation	Hydrocortisone supplementation	-

Primary Outcome Measures

Name	Time	Method
Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session	30 min	Cortisol at T0 and T30mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session

Secondary Outcome Measures

Name	Time	Method
potential drug interactions (including CYP450 inducer)	6 months	potential drug interactions (including CYP450 inducer)
cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure	6 months	cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure
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	30 days	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