Haematological Malignancy
Conditions
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
Interventions
OTHERHydrocortisone 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
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| potential drug interactions (including CYP450 inducer) | 6 months | 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 | 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 |
Contacts
PRINCIPAL_INVESTIGATORBrieuc Cherel, MD
Rennes University Hospital
Outcome results
None listed