Clinical trial NCT03688789: Hématologie Adulte Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology
Official title: Prevalence of Adrenal Insufficiency Post-chemotherapy Adrenocorticotropia in Adult Hematology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Haematological Malignancy
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session
timeFrame: 30 min
Secondary outcomes:
measure: cumulative doses of corticosteroids in prednisone equivalent as well as duration of exposure
timeFrame: 6 months
measure: potential drug interactions (including CYP450 inducer)
timeFrame: 6 months
measure: 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
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Rennes University Hospital
name: Brieuc Cherel, MD
role: PRINCIPAL_INVESTIGATOR
References: